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Senior Drug Safety Specialist

2 weeks ago

Rajkot, Gujarat, India beBeeRegulatory Full time US$ 80,000 - US$ 1,10,000
Pharmacovigilance Leader

We are seeking a highly skilled and experienced Pharmacovigilance leader to oversee our PV system, ensuring compliance with local and global regulations.

  • Manage the organization, maintenance, and compliance of our Pharmacovigilance (PV) system
  • Maintain awareness and adherence to established processes, guidelines, national, and international regulations for pharmacovigilance
  • Ensure PV business continuity and after-hours availability
  • Lead and coordinate internal and external PV audits and inspections
  • Monitor PV system performance and compliance of partners and distributors
  • Stay updated on country and worldwide regulations and promote awareness of legislative and regulatory environments
  • Accountable for all strategic PV activities
  • Contribute to monitoring the safety profile through active participation in pharmacovigilance system activities
  • Be the responsible contact person in the region for safety-related aspects and PV
  • Document internal regulatory/PV processes and procedures to support compliant regulatory/PV activities

Key Responsibilities:

The successful candidate will be responsible for:

  • Developing and implementing PV strategies
  • Leading cross-functional teams
  • Ensuring compliance with regulations
  • Monitoring PV system performance

Requirements:

  • In-depth knowledge of national/regional regulatory legislation and guidelines
  • Knowledge of pharmacovigilance regulations worldwide
  • Excellent organizational, facilitation, and interpersonal skills
  • Experience in people management, including vendor oversight in compliance/regulated fields
  • Capacity to troubleshoot and manage multiple projects simultaneously
  • Strong knowledge of medical terminology and clinical development processes
  • Rational approach to issues and their business implications
  • Highly analytical with attention to detail
  • Excellent organizational skills and ability to work efficiently
  • Excellent communication skills, including verbal and written English proficiency

Qualifications:

  • Minimum five years of experience within the pharmaceutical industry and five years within pharmacovigilance
  • Degree or Advanced degree in medicine or life sciences, or equivalent experience
  • Proficiency in Microsoft Word and Excel
  • Experience in affiliate medical functions or global clinical product development is advantageous