Job Description

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.

The base pay for this position is N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY: Product Development
DIVISION: EPD Established Pharma
LOCATION: India
Mumbai : BKC Building
ADDITIONAL LOCATIONS:
WORK SHIFT: Standard
TRAVEL: Not specified
MEDICAL SURVEILLANCE: Not Applicable
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)