JOB DESCRIPTION:
JD:
- Serve as the companys 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)