Advanced Pharmacovigilance Expert

1 day ago

Kottayam, Kerala, India beBeePharmacovigilance Full time ₹ 15,00,000 - ₹ 20,00,000

Improve Your Career as a Pharmacovigilance Professional

About the Role

We are seeking a highly skilled and experienced Pharmacovigilance Manager to join our team. As a key member of our organization, you will be responsible for managing and maintaining a compliant Pharmacovigilance system.

Your primary focus will be on ensuring awareness and adherence to established and updated local and global processes and guidelines as well as national and international regulations and guidelines for pharmacovigilance.

You will also lead and coordinate internal and external PV audits and inspections, monitor PV system performance and compliance of partners and distributors, and maintain expertise in country as well as worldwide regulations and guidelines.

In addition, you will promote increased awareness of the legislative and regulatory environment in the country and be accountable for all strategic PV activities.

Main Responsibilities:

  • 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
  • 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

Key Requirements:

  • 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 skills

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

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