Pharmacovigilance Reporting Lead

Executive / Assistant Manager- Pharmacovigilance- Aggregate Reporting

Experience: 7 - 12 years

Qualification : B Pharm / M Pharm

RESPONSIBILITIES

• Oversight of all aggregate reporting activities including experience in people management/ project handling/task assignment.
• Prepare and maintain PV documents, standard operating procedures (SOPs) and work instruction (WI).
• Train the PV team and relevant stakeholders on SOPs and Wis
• Organize trainings to corporate office staff and new joiners, Manufacturing plants and other vendors if applicable.
• Prepare and review Aggregate reports [Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs)] and Risk Management Plans (RMPs) or any other document as requested by regulatory a...