Job Description

JD:

Serve as the company's subject matter expert on drug safety and pharmacovigilance Ensure compliance with Local & Global PV-relevant Heath Authority requirements Oversee PV Contracts, vendor management and PV system audits/inspections Have good understanding of signal management and benefit-risk evaluation activities Develop and implement Risk Management Plans (RMPs) and additional Risk mitigation measures Act as the primary safety liaison with country regulatory authorities and internal stakeholders Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and Quality Assurance, marketing teams etc. Contribute to clinical trial safety strategies and protocols (e.g., protocols, safety monitoring plans, SAE reporting etc.) Mentor and develop PV team members to maintain a culture of continuous improvement and compliance Manage departmental budgets, staffing, and resourcing in line with organizational needs

QUALIFICATIONS:

Advanced degree in Medicine or Pharmacy

MINIMUM 10 YEARS

of progressive pharmacovigilance experience in the pharmaceutical industry In-depth understanding of Local/global PV regulations and guidance Demonstrated experience in leadership roles with proven ability to build and scale PV systems. * Strong analytical, strategic thinking, and communication skills.