Experience
10 - 12 yrs
Job Location
Mumbai, India
Vacancy
1
Designation
Head Nurse
Job Type
ONSITE
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
- 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.
Keywords
clinical trial safety strategiesvendor managementsignal managementbenefit-risk evaluationdrug safetyPV system auditspharmacovigilanceSAE reporting
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