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...
We鈥檝e updated our privacy policy so that we are compliant with changing global privacy regulations and to provide you with insight into the limited ways in which we use your data.
You can read the details below. By accepting, you agree to the updated privacy policy.
