Safety PV Specialist II/ Principal PV Spl

Safety & Pharmacovigilance Specialist

Roles & 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.

• Collaboration & Communication:

• Liaise with a variety of 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.

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.