Safety PV Specialist II/ Principal PV Spl

2 weeks ago

Delhi Hyderabad, India Syneos Health Full time
Job Description

We are looking for a skilled and dedicated Safety & Pharmacovigilance Specialist to join our team. This role is responsible for the collection, processing, and reporting of adverse event data, ensuring compliance with global regulations and company standards. The ideal candidate will have hands-on experience in pharmacovigilance and a strong understanding of safety reporting requirements to contribute to patient safety.

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.

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