Assistant Pharmacovigilance Manager
1 day ago
Job Role: Pharmacovigilance (Aggregate Reporting)
Designation: Assistant Manager
Job Description:
- Preparation and review of aggregate reports such as Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Risk Management Plans (RMPs), Addendum to Clinical Overview (ADCO) etc.
- Co-ordination with various stakeholders to gather data required for Aggregate reports.
- Work closely with service providers and resolve their queries.
- Co-ordinate with various stakeholders internal and external required for the completion reports.
- Preparation and review of Query responses from Regulatory Authority
Job Specification:
B. Pharm/ M. Pharm with 6-12years of experience in Pharmacovigilance. Should have experience in medical writing and be able to work independently on PBRER/ PADER/ RMP reports.
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