Safety PV Specialist

7 hours ago

Hyderabad Secunderabad Telangana Delhi, India beBeePharmacovigilance Full time ₹ 1,04,000 - ₹ 1,30,878

We are seeking an accomplished professional to fill the role of Safety PV Specialist II/Principal PV Specialist.

This position requires a skilled and dedicated individual with expertise in pharmacovigilance and safety reporting.

  • Key Responsibilities:
  • Process and manage 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.
  • Conduct a comprehensive review of case information to ensure data quality and integrity.
  • Reporting and Compliance:
  • 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 and Assurance:
  • 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.
  • Collaboration and Communication:
  • Liaise with stakeholders, including clients, clinical teams, data management, and regulatory affairs, to resolve safety-related queries.
  • Provide support and training to junior team members as needed.
  • Requirements:
  • 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.
  • Preferred Qualifications:
  • Excellent attention to detail, strong analytical skills, and a commitment to data accuracy.
  • Effective communication and interpersonal skills.

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