JOB AS Pharmacovigilance ExecutiveEmcure Pharmaceuticals Limited .."R"

Pharmacovigilance Executive/asst. manager at Emcure Pharmaceuticals Limited 
Emcure Pharmaceuticals Limited - Pune,

Roles and Responsibilities: Case processing, triage, signal detection. Preparation of Individual Case Safety Report (ICSR) preparation, review approval and submission of Risk Management Plan. Preparation and Monitoring quality of PSURs (for Europe), Periodic Benefit Risk Evaluation Report (for Canada, Mexico, Russia, Australia & African regions) & PADERs (for US) in the review stage against standards (SOP & GVP, ICH E2c (R2)and applicable regulatory guidelines) to identify inconsistencies and inaccuracies. Extracting data from the database like Case Line listings and PSUR, ADR tabulation etc. Preparation of response to assessment reports received from regulatory agencies DCGI, US, EU etc. Contributing to the timely preparation of ad-hoc and aggregate reports for Domestic, US, EEA and Rest of world  Desired Candidate Profile Roles and Responsibilities: Case processing, triage, signal detection. Preparation of Individual Case Safety Report (ICSR) preparation, review approval and submission of Risk Management Plan. Preparation and Monitoring quality of PSURs (for Europe), Periodic Benefit Risk Evaluation Report (for Canada, Mexico, Russia, Australia & African regions) & PADERs (for US) in the review stage against standards (SOP & GVP, ICH E2c (R2)and applicable regulatory guidelines) to identify inconsistencies and inaccuracies. Extracting data from the database like Case Line listings and PSUR, ADR tabulation etc. Preparation of response to assessment reports received from regulatory agencies DCGI, US, EU etc. Contributing to the timely preparation of ad-hoc and aggregate reports for Domestic, US, EEA and Rest of world  Experience Required : 2 to 5  Education Required : UG - B.Pharma - Pharmacy, MBBS - Medicine PG - M.Pharma - Pharmacy, PG Diploma - Any Specialization Doctorate - Doctorate Not Required

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