drjobs Head Pharmacovigilance India

Head Pharmacovigilance India

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1 Vacancy
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Job Location drjobs

Mumbai - India

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

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)

Employment Type

Full-Time

Company Industry

About Company

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