Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Analyst
Qualifications:Bachelor of Pharmacy/Master of Pharmacy/BSc. Nursing
Years of Experience:1 to 3 years
About Accenture
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What would you do? Prepare and review PSUR/ PBRER/DSUR/PADER/ Addendum Statement/Addendum to clinical overview/US IND reports/ Aggregate finding safety reports/Local reports/ Cumulative Review/Health Authority requests / Health Authority assessment reports as per the applicable procedural documents on the project. Perform scheduling of reports, and author, peer review, publishing and tracking activities of assigned reports. Perform request for inputs activity for the reports (based on the RFI [request for information] and as per the applicable process and SOPs). Send the case closure request and request for Line Listings/Summary Tabulations, as applicable. Initiate, organize, and lead the strategy meeting for evaluation of safety topic/request. Prepare meeting minutes and distribute final minutes with all invitees. Pharmacovigilance Operations involve monitoring and assessing the safety of pharmaceutical products. This includes detecting, evaluating, and preventing adverse effects or any other drug-related problems. The goal is to ensure that
📌 Pharmacovigilance Services Analyst (Bengaluru)
🏢 Accenture in India
📍 Bengaluru
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