Personal Information
Organization / Workplace
Pune Area, India, TN India
Occupation
Senior Pharmacovigilance Consultant
About
Highly ambitious professional with diverse pharmaceutical, device, and service industry experience in global drug safety/ Pharmacovigilance, Risk management.
My capabilities and service offerings include the following:
A) PHARMACOVIGILANCE:
1. Safety Surveillance and Risk Management (including preparation of RMP/REMS)
2. Signal Management & Safety data analyses
3. Global Labeling activities (for CCDS, SmPC, USPI, PIL, Dear Doctor letter etc.)
4. AE Case Management (ICSR processing)
5. Aggregate reports (PSUR/PBRER, AR, SBR, PADER, EU ASR, US IND-NDA)
6. Medical review & Quality Check (QC) of ICSR, all types of Safety & Regulatory documents, Publications, Medical literature or promotional...
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