Head Drug Safety CLIN BIOSCIENCES
CLIN BIOSCIENCES
Office Location
Full Time
Experience: 5 - 5 years required
Pay: INR 1600000 - INR 2800000 /year
Type: Full Time
Location: Bangalore
Skills: drugsafetyindia, directorpharmacovigilance, headdrugsafety, pharmacovigilancelead, riskmanagementplan, globalpvhead
About CLIN BIOSCIENCES
Job Description
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
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MBBS / MD / PharmD / PhD / MPharm / BDS (mandatory depending on regulatory scope)
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Additional certifications in GVP, ICH-GCP, Drug Safety, or PV Compliance are preferred
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Proven experience with regulatory authority interactions, inspections, and PV audits.
Interested to apply can share CV or call/WhatsApp to 9342735755