5.0 - 10.0 years

0 - 0 Lacs

bangalore, noida, hyderabad

On-site

Roles and Responsibilities Lead global and local PV teams including medical reviewers, case processors, and safety scientists. Oversee ICSR management, medical assessments, signal detection , and aggregate report submissions (PSUR, PBRER, DSUR). Define and implement company-wide drug safety strategy aligned with regulatory expectations (CDSCO, EMA, FDA, MHRA, PMDA). Ensure full compliance with global PV regulations , including GVP Modules, ICH E2E/E2D , and local Indian guidelines. Liaise with Regulatory Affairs, Medical Affairs, Quality, Clinical, and R&D functions. Represent the company in regulatory inspections, audits , and safety governance boards . Review and sign-off on Risk Management Plans (RMPs) , Safety Data Exchange Agreements (SDEAs) , and PV SOPs . Guide implementation of PV systems and databases (e.g., Argus, ArisGlobal, Veeva Vault Safety). Lead PV input for due diligence, licensing, and product launches . Qualifications MBBS / MD / PharmD / PhD / MPharm / BDS (mandatory depending on regulatory scope) Additional certifications in GVP, ICH-GCP, Drug Safety, or PV Compliance are preferred Proven experience with regulatory authority interactions , inspections, and PV audits. Interested to apply can share CV or call/WhatsApp to 9342735755

Posted 2 days ago

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