Job Description
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 authorities.
Submit aggregate reports to regulatory authorities.
Preparation and maintenance of PADER and PBRER calendar.
Prepare PV agreements (SDEA) with par...
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 authorities.
Submit aggregate reports to regulatory authorities.
Preparation and maintenance of PADER and PBRER calendar.
Prepare PV agreements (SDEA) with par...
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