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Safety PV Specialist

2 weeks ago

Pune Chennai Bengaluru Bangalore, India beBeePharmacovigilance Full time ₹ 9,00,000 - ₹ 12,00,000
Job Title: Safety PV SpecialistWe are seeking a skilled professional to join our team as a Safety PV Specialist.The ideal candidate will have experience in pharmacovigilance and safety reporting, with a strong understanding of global regulations and industry standards.Key Responsibilities:
  • Collect, process, and report adverse event data in compliance with regulatory requirements.
  • Perform end-to-end management of Individual Case Safety Reports (ICSRs), including data entry and coding using MedDRA and WHO-DD.
  • Ensure timely and accurate processing of adverse event reports from various sources.
  • Conduct comprehensive reviews of case information to ensure data quality and integrity.
  • Prepare and submit expedited and periodic safety reports to global health authorities within required timelines.
  • Maintain and update pharmacovigilance documentation, including SOPs and safety management plans.
Required Skills and Qualifications:
  • Bachelor's degree in a life sciences, medical, or pharmacy-related field.
  • Proven experience in pharmacovigilance or drug safety role.
  • Strong understanding of pharmacovigilance principles, processes, and global regulations.
  • Proficiency with safety databases such as ARGUS, ARISg, or similar systems.
  • Knowledge of MedDRA and WHO-DD coding.
  • Excellent attention to detail, analytical skills, and commitment to data accuracy.
  • Effective communication and interpersonal skills.

As a Safety PV Specialist, you will play a critical role in ensuring the safety of patients by identifying and mitigating potential risks associated with pharmaceutical products. If you have a strong background in pharmacovigilance and a passion for delivering high-quality results, we encourage you to apply for this exciting opportunity.