Santosh Pattanayak

Global Pharmacovigilance Scientist (Gpvs) @Tata Consultancy Services

Pune, IN

Activities related to the preparation, writing and review of periodic aggregate safety reports (PBRERs, PAERs/PADERs, DSURs, SSURs, ACOs)• Review adverse event data, literature, and other Safety relevant data for the purpose of signal detection• Evaluate safety signals and write up analysis results and participates in governance meetings as required• Activities related to clinical trials• Activities related to regulatory commitments: Immunogenicity reports, medical evaluation reports (Health Hazard Assessments [HHAs] and Medical Opinion Memos [MOMs], Heath authority requests• Provide oversight and is an expert advisor to junior PV Scientists to ensure the activities are performed according to Standard Operating Procedures and/or may be responsible for following the tasks as outlined for the Global Pharmacovigilance Scientist• Provide training, coaching, mentoring, and development of staff

Savitribai Phule Pune University

M.pharm, Pharmacology