Senior Pharmacovigilance Director

3 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878
Pharmacovigilance Leadership Role

We are seeking a seasoned Pharmacovigilance professional to lead our team and drive compliance, regulatory submissions, and pharmacovigilance SOPs.

  1. Job Summary:
  2. This role involves handling end-to-end Case management activities, ensuring compliance with regulations, and guiding the pharmacovigilance team on aggregate reports and regulatory submissions.
  3. You will be responsible for developing and reviewing pharmacovigilance SOPs, coordinating ICSR activities, and providing guidance and training to the team as needed.
  4. The ideal candidate will have strong leadership skills, excellent communication abilities, and in-depth knowledge of pharmacovigilance practices.
  5. Key Responsibilities:
  6. Lead the pharmacovigilance team and ensure that all tasks are performed according to guidelines and standard operating procedures.
  7. Consult and guide the team on completion of aggregate reports and regulatory submission documents.
  8. Develop and review pharmacovigilance SOPs to ensure compliance and best practices.
  9. Coordinate ICSR activities and regulatory compliance efforts.
  10. Provide guidance and training to the team on pharmacovigilance best practices.
  11. Required Skills and Qualifications:
  12. Possess in-depth knowledge of pharmacovigilance practices and regulations.
  13. Strong leadership and communication skills.
  14. Ability to develop and implement SOPs and processes.
  15. Experienced in case management and aggregate reporting.
  16. Familiarity with regulatory submissions and PV document preparation.
  17. Benefits:
  18. Opportunity to lead a high-performing team.
  19. Contribute to the development of pharmacovigilance SOPs and processes.
  20. Collaborate with cross-functional teams to drive regulatory compliance.
  21. What We Offer:
  22. A dynamic work environment with opportunities for growth and development.
  23. A competitive salary and benefits package.
  24. The chance to make a meaningful impact in the field of pharmacovigilance.

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