What skills are important in PV other than PV?

 What skills are important in PV other than PV?

Many of us who are SME (Subject matter experts) are always under impression than knowing my domain and being hardworking will help me in my career and i don't need anything else. I was under the same rock, being a nerd my whole life (off course i am doctor) i was huge believer of this myth at least for a year or two in my new job.

Fortunately, i had great mentors, bosses, colleagues and leaders who bust my myth and helped me build whatever career i wanted to achieve one step, one skill and one learning and one training at a time.

 So if you are in pharmacovigilance career and you are limiting your learnings to regulatory guidance documents, clinical and pharmacology knowledge then you are in a surprise because guess what is needed for all that knowledge you have to be put into actions and then demonstrate you bring value and outcome to the organization- yes you guessed it those are your non-technical skills which people call soft skills, behavioral skills etc.

It never too late for us to shift from what my favorite author says "knower to learner". SO lets dive in what other skills you need apart from sound and working PV knowledge.

 1. Project management: 

Yes, if you don't have PMP certificate its ok, but working knowledge is must. Because PBRER, DSUR, PSUR, Signal reports, RMP, PSMF -they are projects. 

They have multiple writers, compilers, reviewers and they have strict external timelines. So dust your skills on what it means to have RACI matrix, KPI, KOM. Even a SUSAR is project with 15day/7 day timelines and you have data entry, medical review or quality review from different people that needs to happen on time with quality and final step is submission. 

How do you handle this projects? will you be their manager ? nope, not always and even if you are then you have more responsibility . This are individual tasks given to you if you have team or not. So you need to learn how to clear accountable, responsible delegation, expectation setting and tracking to deliver this.

2. Communication skills:

 How to have clear, defined and courageous and brave communications. This means written and verbal. You are responsible for safety of patients, your voice matter. Own your expertise and communicate the impact of product in signal meetings, in PSUR, DSUR or even ICSR (DOES THIS CASE impacts case, is it related or not related). Communicating clearly so you present your knowledge is must. 

You work in strictly regulated environment and strict timelines, asking for what you need and giving what you promised needs clear communication with who, when, what and how and also why.

3. Time management:

Time management skills, which I like to say is time utilization is to use your time effectively to deliver expected results. These means allocate your time properly and accomplish tasks efficiently. 

When you have SUSAR, a section in PSUR and signal report due in one week, how do you allocate time? If you are a manager add to this list, performance reviews, unexpected sick leaves and so on. Learning how to allocate time is must.

 4. Prioritization: 

You can achieve more when you start dedicating time to the right things. But how do you know what those things are? Eisenhower's principle explains this nicely, which you can google. What it means is in PV everything can feel like its urgent, so use your SME skills, know what are timelines for SUSAR, PSUR, DSUR etc so you know which to prioritise. In addition, some tasks may simply don’t have defined timelines, then also you need to know how to prioritise them.

 5. Business skills: 

As PV SME, you may work for CRO/Vendor or MAH. When you are working in service side, you will be required to know how to do business capability presentations, upsell, crossell, pricing for ICSR, SUSAR, PADER etc. You will be required to negogiate, engage and finalise business agreements with partners, clients etc. Even if you are working for MAH/Pharma you need to know what is strategy for my product, what is the revenue, what are the plans and how PV can support that product to ensure its thriving in market.

 6. Tools: 

Many people believe that as PV SME they just need to know safety database, literature database and maybe few signal database and that’s the only tools they need to know. Yes we will spend majority of our time in the PV systems, but we will need to use word (author, compile, review) PSUR ,DSUR, RMPs so you need to know how to use word ( insert footnotes, bibliography, TOCs, hyperlinks and more complex commands). You need to know excel- how to calculate number of case, events, present cases by patient age, gender in pivot table, create signal reports etc. We also need to know power point, leading, contributing to kick of meetings for aggregate reports, RMP, PSMF, Signals etc.

This are very few that i have listed, and yet i am still developing them. The goal is to keep learning and implementing.

Written by:

Dr.Shraddha Bhange.

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