Senior Pharmacovigilance Specialist

3 days ago

Hyderabad Secunderabad Telangana Delhi, India beBeePharmacovigilance Full time ₹ 1,04,000 - ₹ 13,08,780

Job Description

We are seeking an experienced and skilled Senior Pharmacovigilance Specialist to join our team. The ideal candidate will have hands-on experience in pharmacovigilance and a strong understanding of safety reporting requirements to contribute to patient safety.

Responsibilities:

  • Case Processing:
  • Perform end-to-end management of Individual Case Safety Reports (ICSRs), including data entry, coding of adverse events using MedDRA, and drug coding using WHO-DD.
  • Ensure timely and accurate processing of adverse event reports from various sources (e.g., clinical trials, spontaneous reports, literature).
  • Conduct a comprehensive review of case information to ensure data quality and integrity.
  • Regulatory Reporting:
  • Prepare and submit expedited and periodic safety reports to global health authorities within required timelines.
  • Ensure all reporting activities are in full compliance with ICH guidelines, GVP modules, and other relevant local and international regulations.
  • Assist in the preparation of aggregate reports such as PSURs/PBRERs.
  • Quality & Compliance:
  • Participate in internal and external audits and inspections, ensuring readiness and addressing any findings.
  • Maintain and update pharmacovigilance documentation, including SOPs and safety management plans.
  • Conduct quality control checks on processed cases to ensure accuracy and consistency.

Qualifications:

  • A degree in a life sciences, medical, or pharmacy-related field.
  • Proven experience in a pharmacovigilance or drug safety role.
  • Strong understanding of pharmacovigilance principles, processes, and global regulations.
  • Proficiency with safety databases such as ARGUS, ARISg, or a similar system.
  • Knowledge of MedDRA and WHO-DD coding.
  • Excellent attention to detail, strong analytical skills, and a commitment to data accuracy.
  • Effective communication and interpersonal skills.

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