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Clinical Research Specialist

2 weeks ago

Mumbai, Maharashtra, India beBeePharmacovigilance Full time ₹ 25,00,000 - ₹ 40,00,000
Job Title: Pharmacovigilance Manager

As a trusted partner to the pharmaceutical industry, we deliver comprehensive clinical research services that ensure efficient and effective research outcomes.

Key Responsibilities:

  • Organize, manage, and maintain a highly compliant Pharmacovigilance (PV) system
  • Maintain awareness and ensure adherence to established and updated local and global processes and guidelines as well as national and international regulations and guidelines 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.
  • Maintain expertise in country as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the country.
  • Accountable for all strategic PV activities.
  • Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile.
  • Act as the responsible contact person in the region, internally and externally, for safety-related aspects and PV.
  • Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities.

Requirements:

  • In-depth knowledge of national/regional regulatory legislation and guidelines.
  • Knowledge of the pharmacovigilance regulations of all the countries.
  • Demonstrated ability to provide quality work using strong organizational, facilitation, and interpersonal skills in a cross-functional team locally, within PV and externally.
  • Skilled at people management including overseeing and controlling outsourced vendor activities in a compliance/regulated field.
  • Capable of troubleshooting and managing multiple projects simultaneously.
  • Strong knowledge and understanding of medical terminology and clinical development processes.
  • Rational approach to issues and their business implications, good problem-solving, and decision-making skills.
  • Highly analytical with the ability to give attention to detail.
  • Excellent organizational skills and capable of working efficiently.
  • Possess an excellent interpersonal, verbal, and written communication skill.

Qualifications:

  • Minimum five years of working experience within the pharmaceutical industry and minimum five years within pharmacovigilance.
  • Degree/Advanced degree in medicine or in life sciences or equivalent experience.
  • Excellent communication skills including proficiency in verbal and written English.
  • Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global clinical product development is considered advantageous.
  • Proficiency in Microsoft Word and Excel.