Head Pharmacovigilance

Abbott

10 - 15 years

25 - 30 Lacs

Mumbai

Posted:15 hours ago| Platform:

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Skills Required

Medical affairs Manager Quality Assurance Analytical Pharmacy clinical development Pharmacovigilance Continuous improvement Risk management Drug safety Monitoring

Work Mode

Work from Office

Job Type

Full Time

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.

JOB FAMILY: Product Development

LOCATION: India > Mumbai : BKC Building

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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