10 Best Career Options For PV Exp Professionals
PV Chronicle Shared Pharmacovigilance (PV) career for fresher’s and clarified few of the basic doubts pharmacovigilance scope. Recently we have received the lot of requests about career options for experienced Pharmacovigilance professionals, especially ICSR Case processors.
PV Chronicle editorial team researched, analyzed and sharing the 10 best career options available in the IT Life Sciences industry. Our team tried to compile the best career options available, approach and skills required for trying new career options. At this point in time, we can recollect 2 evolution theories Survival Of The Fittest and Struggle For Existence. While we were trying to get our first PV job its Struggle For Existence. Being experienced and Survival Of The Fittest come to remembrance.
We suggest you upskill your learnings and one should look at the career with the long-term vision for the next five to ten years, where you want your career to land and progress.
- Aggregate Reporting/RMP/Signal Detection: Best option is this, continuing in the same Pharmacovigilance domain and learning the broader part of core PV activities like aggregate report-preparation, Periodic Safety Update Report (PSUR), PADER, Drug Safety Updated Report (DSUR), Annual Safety Report (ASR) and Risk Management Plan (RMP). These kinds of learning are possible in sponsor pharma companies and few contract/clinical research organization and IT companies where Drug Safety Professionals are provided a chance of learning end to end PV activities.
- Pharmacovigilance Consultant: Experienced pharmacovigilance professionals can start their own consulting services as a consultant or freelancer to upcoming new start-up CRO’s and IT companies. If you are capable of providing end to end consultation/Subject Matter Expert (SME) for PV activities, consulting plays a major role while establishing it, skills required would be strong knowledge of PV regulatory guidelines, good understanding of legislation, safety database vendor selection, customization, installation implementation and support the organization in the preparation of Standard Operating Procedure (SOP)’s. To name few PV consultants in India are Darshan Patel and Moin Don, Founder of PVCON, Mumbai.
- Pharmacovigilance Trainers: Pharmacovigilance professionals who are experienced in ICSR, PSUR, RMP and Signal detection can kick-start a new job role a trainer within the same organization. Joining hands with nearby training institute or as a freelancer. The skills required is good communication, presentation and updating themselves with the latest guidelines to cater to the needs of PV industry. The trainers play the key role while onboarding fresher’s, Drug Safety database training, sharing the sponsor guidelines and setting the expectations of the company and clients. Women, who had good PV experience and dropped career due to personal or maternity break can think of choosing this option by joining as a trainer in any nearby institution or as a freelance trainer for online training.
There is a huge demand for experienced and effective trainers. Just try a new role as a trainer, who knows the best trainer may be you.
- Business Analyst: This role is predominant and excellent career option out in PV domain or any healthcare domain. Good communication, presentation and analyzing skills set are mandatory for this Job role. Pharmacovigilance Business Analyst would be playing more of a functional consultant role. To be a Business Analyst join a course and upgrade your skill to fit into the industry. Business Analyst should be able to prepare User Requirement Specification (URS), Functional Requirement Specification (FRS) and liaise with sponsors/pharma companies and IT teams.
- Functional Consultant: Functional consultant to be well equipped with the latest regulatory guidelines and understand the Sponsor/Pharma company requirements. Function consultants act as a liaison between the sponsor and core IT, professionals. These consultants support in User Acceptance Testing (UAT), Database customization, functional testing i.e performing Performance Qualification (PQ) scripts. More of domain knowledge to be acquired on regular basis.
- Techno Functional Consultant: Techno Functional consultant to be well equipped with latest regulatory guidelines i.e EMEA, 21 CFR, US FDA and technical skills like SQL, PL SQL, manual testing including UAT, preparation of UAT Protocols, scripts, Installation Qualification (IQ), Operation Qualification (OQ) and PQ documents. These consultants are core team who take requirements from functional consultants, customizes the safety/clinical database and supports the stakeholders during the upgrade of database version and data migrations. Techno-functional consultants are very limited in PV domain and are in a huge demand.
- Computer System Validation: This department falls into compliance and Quality assurance as a Drug Safety Professionals everyone are aware, how important the compliance and kind of key role its play in Gxp, Pharma Industry. Every pharmaceutical company equipment, instruments and equipment’s to be GXP compliant. In the similar fashion the software applications used in CRO’s and IT companies, to be GXP compliant, where CSV professional is required. This kind of job role is present in both Pharma and IT Companies.
- Medical Writing: One more career option, who are interested in narrative writing and scientific writing and having experience in PV can choose this profile.
- Clinical Data Management: Clinical Data Management (CDM), CRO’s like PPDI, Parexel, IQVIA, and Icon offers internal job postings which allow switching profile. Based on your interest try to switch your job profile within the company, which is always a better idea.
- Regulatory Affairs: Though this profile is listed in the last of this article, this job profile is evergreen and the best in the industry. You can start regulatory affairs job role by involving in the submission of reports to regulatory authorities.
Start exploring the above mentioned 10 Best Career options for experienced PV Professionals through your graduation or post-graduation circles. The decent thought is to connect professionals and HR’s on LinkedIn, request for a reference and share your interests via message. Of course, switching profile with more number of years is a bit tough task, but if needed get trained and give a try for the new career path. If needed get trained from institutions or join any online trainings. All the best friends.
Will complete this article with our favorite and ever Inspiring education quote.
Investment On The Education Pays You Best Interest…Benjamin Franklin
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