Qualification: MBBS (MCI certification MBBS from out of India)

Experience: 2-4 years of experience in pharmacovigilance with experience in medical review of ICSRs, aggregate reports &/or signal detection.

Plz. note that M.Pharm candidates do not apply

Job Responsibility
Perform medical review of ICSRs including but not limited to verification of MedDRA coding, event pulling, causality assessment and expectedness assessment. Responsible for writing lucid and medical cohesive company causality comments in ICSRs.
Perform medical review of literature articles as a part of signal detection activity and medical review of other signal management reports.
Perform medical review of aggregate reports including but not limited to benefit risk evaluation, literature evaluation and evaluation of risks and signals.
Perform medical review of Risk Management plans.
Participate in safety label update activities for assigned products
Provide product and therapeutic area trainings to PV team.
Provide cross-functional training on pharmacovigilance to medical writing and ICSR team members

Additional Requirements
Candidate should be willing to work in evening shifts, weekends and public holidays as per Roster Plan.

Please share your profile at aruna.tanwar@fresenius-kabi.com, if you are interested.