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...
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...
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