Head Drug Safety

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

• GVP, ICH-GCP, Drug Safety, or PV Compliance

• regulatory authority interactions

Interested to apply can share CV or call/WhatsApp to 9342735755