Disclaimer

The ideas, views and opinions expressed in here in blog or comments and profile represent my own views and not those of any of my current or previous employer .They are based and taken from regulatory guidance available freely and my interpretations from my experience.

Saturday, 29 June 2019

Pharmaceutical Career options for healthcare professionals



Job opportunities in Pharma!!!!!

Lot of healthcare professionals want to venture in the world of corporate pharmaceutical industry but yet, many remain skeptical and clueless.Reasons for it are many and one of the reasons is sometimes they have an idea from google or someone they know, but they want to know more from someone who can direct them in more detailed manner.Unfortunately this someone is not available easily with honest guidance. (*I have special reference to one of the institutes offering excellent courses in this domain at the the end of my blog,do check).

I came to know this situation, because I get approached by many MBBS/BDS/BAMS/B.Pharm  pass out students on how do they start their journey and what is career prospects in this domain? Most of the time, they approach me on facebook/linkedin/Quora where it is really difficult to summarize and guide them via chat.Hence this blog.

But before i open the topic, i would like to clarify that I am not an industry expert neither claim to have deep knowledge in this area.  I have decided to write my 2 cents of knowledge to help someone looking for a starting point to begin their career in pharmaceutical industry.

To start with, I have enlisted few of the different areas in Pharma industry where healthcare professionals are required along with the job titles as an example below. But this is neither exhaustive list nor it is bulletproof, it should be taken just as reference.

  1. Clinical operations
shutterstock


We do know that clinical research is the backbone of getting newer or lets say better drugs in the market. Conducting  clinical research is a long term process which involves multiple stakeholders including  physicians and other HCP (health care professionals). 

To run a clinical research project i.e. clinical study/trial, pharmaceutical companies need people who understand the patient and his/her medical status to understand the disease, the medicinal product being researched, how it will help the disease etc. Companies are looking for a healthcare professional with good understanding of clinical trials, inclusion/exclusion criteria to recruit patients, monitoring of the trials, writing clinical protocols, taking informed consent from patients, and to monitor the safety of patients during clinical trials and so on.
The Job titles that are most commonly referred are Medical Monitor, CRA, Clinical and Safety Associate/Manager/Head. As someone gradually progresses in career, usually  the preference is for MD.Pharmacology for the topmost position in department (at least in India).
 
www.nia.nih.gov
2. Pharmacovigilance (PV)
There is tons of information including definition of pharmacovigilance online, but instead of technical jargon, I am taking the approach of writing it in layman's language. So basically  PV is about collection and analysis of side effects or adverse events associated with drugs and then taking decision regarding the drug based on data collected to ensure drugs are safe for patients as treatments.
The job titles or roles available are pharmacovigilance expert/medical reviewer/safety physician/drug safety advisor/medical director/safety leader.
Although the job primarily starts with reviewing the side effects/adverse event reports of patients, it is much more beyond that, extending to the challenging and fulfilling role of being responsible for a drug for its safety and efficacy and taking decisions regarding its life cycle.


3. Medical Affairs
Medical affairs is the most important department which is central glue to all other departments mentioned herein, more so in Indian Pharma companies, where they play varied and crucial role in every domain. The primary role of medical affairs is to help pharma companies to write scientific literature,product information and to meet with the other practicing doctors to create awareness regarding the availability of  their better and effective drugs. Apart from the primary responsibilities mentioned herein, they help in other areas like clinical operations,pharmacovigilance,medical writing etc.
The medical affairs department job titles include Medical advisor/Medical head/brand leader/Medical affairs head,medicomarketing manager(not used much now) etc.

4. Clinical Data management

Well, we are in a world where information is the currency, but unless its converted into meaningful data, it cannot be used, right? Clinical data management forms the core of any pharma company especially those dealing with new products and where clinical data managers play varied roles and responsibilities. They help in collecting and maintaining patient data and all other associated data collected during the clinical trial and store it in secure database,code it,retrieve it, analyse it and so on.

Different titles in this domain are clinical data associate, clinical data analyst, clinical data manager , director etc.
www.indiamart.com

5.Regulatory affairs

The regulatory affairs department  is responsible for obtaining permissions and fulfilling requirement or requests from regulatory agencies/health ministries for company drugs. Different  activities that they perform are  obtaining approval for new drugs from health ministries (they are called as regulatory agency or health authority) and ensuring that permission is maintained for as long as the company wants to keep the product on the market.They also are responsible for different requests such as dossier preparation, maintenance of product information etc as per legal requirements led down by Health authorities.
The different titles available in this field are regulatory affairs associate, manager, director, specialist.

6.Medical writing

Medical writers are responsible for writing medical documents that present information clearly and concisely. This can be any documents such as marketing materials, drug information documents, clinical study protocols, pharmacovigilance reports,IB,clinical study report etc.

There are limited opportunities for MBBS per se, but if someone is passionate then of course,they can find a way.

There are other departments as well in pharma companies for jobs for HCPs, however on practical note, i have presented those that are most commonly known, and are easily accessible to apply for a job role.

Growth opportunities : I would like to finish the topic by putting my 2 cents about growth in this career. Remember that as for any other career same rule applies here too, growth depends on number of factors, your skill, attitude, hardwork and availability of opportunity at right time for you etc. 

Special tip for doctors: Doctors if you do decide to join this domain, you should do it because you actually like it. I have seen many doctors who are not prepared to follow 9 to 5 time routine, deal with documentation, not ready to accept the criticality of the work in absence of actual patient standing in front of them, not ready to learn soft skills needed in corporate sector, not ready to learn new computer skills, and  not ready to apply medicine knowledge in different corporate sector. Please know the differences in hospital and corporate job, and then take conscious decision of joining whichever field appeals to you.



Further reading and training : I will try to include more resources for reading, learning and institutes offering both in my next blog. 
As far the institutes, let me start in this blog post with special mention to RISETRAINING who are doing excellent job in providing courses for Pharmacovigilance, Medical Writing, Computer System Validation and Argus Administrators. They also provide Job Consultation and 100% placement guarantee. And the best part is they are Training Students both online and offline. Check out more details @ http://www.risetrainings.com/

I hope this has given bit more clarity and help to readers, and I wish you the best for your career, whatever field you choose. 

Thanks for reading,

Dr.shraddha Bhange.

Connect with me Via comments below.
Support the cause of better rural education with me:ThinkSharp Foundation http://thinksharpfoundation.org/#home
(Images are taken directly from Google).



Sunday, 23 June 2019

Pharmacovigilance and beyond~old blog with new content



After 3 years of a break, I am attempting to restart writing my blog which will cover pharmacovigilance topics, primarily, and whenever appropriate some other relevant topics.  I am deeply thankful to my old readers and followers who kept on contacting me to write the blog again. I am humbled by their response for my amateur attempt of writing. Although I am no expert in this field the reason of starting this can be summed in below 2 points:                                                                 
  • Learning by sharing knowledge: Pharmacovigilance (PV) is a vast domain which is tightly governed by rules, regulations, guidance’s, which are at times too many to follow and remember. In addition, in PV, the race is against time, to remember these rules/guidelines on time to be compliant with submission to Health Authority is not always possible. Sometimes you have luxury of time and you read, understand and apply this regulations/rules for yourself, but the same luxury is not available to one of your colleagues, who can benefit from your knowledge. With the same intention, I have restarted my blog, to learn together by sharing our knowledge. Particularly Pharmacovigilance knowledge (and other related domain) to be complaint to ensure patient safety!
  • Awareness regarding PV: The other aspect of writing this blog is to create awareness regarding pharmacovigilance and other domains of pharmaceutical industry that make medicines available to patients. A doctor without a treatment for your disease (i.e. drugs/medicines) is like a soldier without weapon in a war. Healthcare professionals working in pharmaceutical industry do work behind the scenes to make these drugs available to patient that are safe and effective.
The posts will be particularly short (I will try my best) and will talk about different interlinked topics such as career options in pharma industry, PV regulations, Regulatory guidelines, hypothetical case scenarios, various medical/clinical topics, diseases etc. But focus will be to cover PV topics.

Thanks for reading,

Dr.shraddha Bhange.

Connect with me Via comments below.
Support the cause of better rural education with me :ThinkSharp Foundation http://thinksharpfoundation.org/#home

Sunday, 3 January 2016

Writing Medical assessment in Pharmacovigilance


With changing times, it is said that we have lost a lot of our attention span and this if applied to our reading, makes us to read something quickly and come to conclusion. 


This is exactly what physicians, health authorities, responsible HCP (Healthcare Professionals) want to read when they read adverse event report preferably CIOMS/MedWatch. They just want to get idea regarding the reported adverse event and the suspect drug and what does the company's position is on this.

Medical assessment is known as company comment, sponsor comment, MAH comment and so on  but in this blog we will term it as medical assessment.The medical assessment or sponsor assessment or company comment is exactly the place where you will find this information.


What is medical assessment?

This is short description (generally not more than 4 to 5 sentences) regarding Sponsor's position with respect to the reported Adverse Event (AE) and Sponsor's suspected products and its relationship to AE in a very brief and conclusive way.


Who should write it?

Many Sponsors* and Regulatory authorities* prefer safety physician’s i.e certified medical doctors to  write it especially for Clinical Trials (CT) and Serious cases. However non serious and post marketing adverse event reports can be handled by experienced pharmacovigilance individuals who are not medical doctors per se but are HCP’s with proper training and expertise. In fact, regulatory guidelines are also not stringent regarding requirement of only medical doctors to write medical comment for all cases in PV , and same is being followed widely in industry.

Prerequisites for writing a comprehensive company comment:
·         Know the safety profile of drug- Refer to IB,RMP,SmPC,PIL .This helps to understand the mechanism of action and safety profile of suspect product in relation to the reported event.
·         Causality assessment- It is a topic, that will be explored in detail in another blog. However the important prerequisite is that causality assessment has to be done so you know your position as to is it a related or not to suspect product. This helps in writing sponsor assessment so that you know how and what to write. 
·         Know the clinical presentation of the event, it is important to know the disease pathophysiology, risk factors etc so as to explain the event and correlation to drug.
·         Know the time to onset/Latency (temporal relationship of the event and product).
·         Knowing safety profile of other concomitant medications. This is not always very easy, especially in patients when conmeds are reported as none or many. The trick is first go by class of drugs and then download the SmPC/PIL/USPI of relevant drugs from company website/RA websites. (You can find such relevant websites on my previous blog)

What and how should it be framed?

Medical assessment is free text field in any Safety database used by Sponsor. Most Sponsors have a standard template to help drafting it.


Some common do’s are:

·         Use full generic drug names (i.e. for the active ingredients) only; no abbreviations.

·         If the case is not assessable due to poor documentation, describe what additional information is needed to determine causality. Ensure you send follow up for this missing information.
·         If required, provide reference of case definitions/literature to support the assessment.
·         Provide the statement regarding the current safety profile of drug in relation to current RSI and event (listedness).

Some common don’ts are:

·         Be concise (e.g. do not repeat case demographics which are already mentioned in case narrative i.e age & sex, unless they contribute to the medical assessment)

·         Avoid abbreviations including obvious one’s as well  e.g COPD,DM,URTI,HB etc .

·         Do not include calendar dates but the number of days from exposure to event (e.g. 2 Days after treatment started) i.e latency; it is acceptable to give approximate dates (e.g. after about two months or 2 years when more appropriate)

·         Avoid mentioning unsubstantiated or non-scientific sources to frame sentences
·         Avoid using very definitive and specific terms or personal opinions like it is highly impossible, not at all related etc.
·         Avoid mentioning assessment for other company suspect products when not needed or when data is inconclusive


Take home message : It is important to remember that the medical assessment should make medical and scientific sense and is standardized ( conveying  same meaning to every reader). It is company statement and the writer should remember that it can be challenged during audits/inspections.

*Sponsor/Marketing Authorization Holder/Manufacturer and RA/HA/NRA/CA (Regulatory Authorities/Health Authorities/National Regulatory Authority/Competent Authority) are used interchangeably for ease in blog but have different definition.

 Written by,


Dr.shraddha Bhange.
Connect with me Via comments below, I do not respond to Facebook messages.
Support the cause of better rural education with me:ThinkSharp Foundation http://thinksharpfoundation.org/#home
.






Wednesday, 25 November 2015

Pharmacovigilance knowledge repository

 One of my friend asked my advice for websites or resource for pharmacovigilance knowledge.


So i tried helping him, but i realized there is not enough one stop here we could find this, at least i have not found one. The list is exhaustive and will be updated, but something to start with.

1) Regulatory websites itself-
This websites are great source for enhancing knowledge or refreshing or simply keeping in touch with regulatory updates.If you subscribe to this website then authenticated first hand updates by regulatory bodies will be delivered to you in your mailbox.

FDA for US regulations, EMEA for European regulations, MHRA for UK regulations etc.

1) FDA website is vast storage of knowledge and once you browse it properly many courses and documents are available. If you subscribe there is also an option to subscribe for your domain only at here-http://www.fda.gov/ForHealthProfessionals/StayInformed/default.htm.

I found an important links to FDA where interesting courses are available.

FDA clinical investigator  program.

FDA  course on new drug development-

FDA all stages of dug development program-

FDA all 101 questions-


2) EMEA website-It is very informative and user friendly, navigation is quite easy and finding topics of your intrest  immeidately is easy too
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000258.jsp

3) MHRA-
UK has its own website dedicated as medicine and health regulatory activities.
Website is very informative, alphabetically SmPC(summary of product characteristics)/ package insert/CCDS  can be found easily on this website if required for any drugs at national level and also for European or other drugs external links are provided for package insert or labelling documents of that drugs.
All the updates are easily viewable on website.
https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety


4) For India-The Central Drugs Standard Control Organization (CDSCO) website is quite informative, but i feel the website needs more information and more updation on frequent basis.

http://www.cdsco.nic.in/forms/Default.aspx

Another website for India is pharmacovigilance program of India http://www.ipc.gov.in/PvPI/pv_training.html

Other country specific website can be found as required on internet but this main guidelines or regulations form basis of most of the globally accepted PV principles.


5) UMC-To start with off course Uppsala monitoring center based in sweden which is headquarters for all PV activities. Although the website is not itself loaded with information it does guide on where to reach for each PV topic etc.

http://www.who-umc.org/DynPage.aspx?id=98079&mn1=7347&mn2=7252&mn3=7323

6) ICH website-
International conference on harmonization is basis of all guidelines for safety and regulatory, website is easy to navigate and subscription is again easy.
All required documents and guidelines like ICH E2A, E2B etc are freely available to download, and advantage is you will always refer to latest guidelines.

7) Training schedules are also available.
http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

8) Other sources are vast but it is important to know the difference between a good source of information and marketed websites.

Few that i found are good and also offer paid or free courses are detailed below.

1) Biopharma institute-This offers basic free PV courses and other information in domain.
http://www.biopharmainstitute.com/training-courses-books/Demo-elearning.php

2) DSRU- This institute provides paid training courses in Europe mostly, check out website the courses appear very well designed and informative.

http://www.biopharmainstitute.com/training-courses-books/Demo-elearning.php

3) EU2P website- This offers courses mainly on European regulations.
http://www.eu2p.org/diplomas-offer/certificates

4) ISOP website- Internatinal society of pharmacovigilance also offers courses and training materials.
http://isoponline.org/

5) Many pharma websites too host lot of updates on pharma domain news like pharmabiz, pharmatutorhttp://www.pti-global.co.uk/, Fierce pharma-http://www.fiercepharma.com/,
IGMP institute India website-/http://www.igmpiindia.org/, applied clinical trials website-http://www.appliedclinicaltrialsonline.com/

6) Blogs- I really love blog Mr.Bart Cobert, a renowned and great PV expert@http://www.telerx.com/author/bart-c/.

Another interesting and great blog is http://sjpharma.blogspot.com/2015/07/changing-dynamic-of-pharmacovigilance.html

Sarjen systems also have their webinars and very informative one's http://www.pvnet.in/.

Many CRO,KPO,BPO and pharma companies do host a space on their website where they ask their PV experts to write articles on PV topics, worth checking out.
It is good to follow organisations like CRO,KPO, Pharma companies that keep on posting articles on PV on their social media account.

7) Social media-
I do not know much about Facebook, but Linkedin is very good tool to keep in touch with domain knowledge, their are many PV groups that you can join where articles on PV topics are posted like Budding regulatory professional, Pharmacovigilance experts, PV India, clinical trial group etc.



Thanks you for going through this exhaustive list, which is just a small effort, if you know any other good source do let me know too.

Till then keep reading,



Dr.shraddha Bhange.

Quora-Quora connect


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