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Assistant Pharmacovigilance Manager (Aggregate Reporting)

Assistant Pharmacovigilance Manager (Aggregate Reporting)

6 - 11 years

|

7 - 10 Lacs

mumbai suburban navi mumbai mumbai (all areas)

Posted:15 hours ago| Platform:

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Skills Required

pharmacovigilance aggregate aggregate reporting pader pbrer

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Role

Designation

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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Pharmaceuticals

Mumbai

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