1 Pharmacovigilance jobs in London
Principal Pharmacovigilance Scientist
SW1A 0AA London, London
£85000 Annually
WhatJobs
Posted 2 days ago
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Job Description
Our client, a globally recognized pharmaceutical company at the forefront of medical innovation, is seeking a highly experienced Principal Pharmacovigilance Scientist to join their esteemed safety surveillance team. Based in London, England, UK , this role is instrumental in ensuring the safe and effective use of medicines by meticulously monitoring, evaluating, and reporting adverse events. The ideal candidate will possess deep expertise in pharmacovigilance regulations, signal detection, risk management, and regulatory reporting, combined with strong analytical and scientific writing skills. This position requires a commitment to patient safety and the ability to contribute significantly to the company's safety profile.
Key Responsibilities:
Key Responsibilities:
- Lead the safety assessment of assigned pharmaceutical products, including signal detection, evaluation, and risk management planning.
- Author and review aggregate safety reports, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and DSURs, for regulatory submissions.
- Contribute to the development and implementation of pharmacovigilance strategies and processes.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to ensure comprehensive safety surveillance.
- Interpret safety data from clinical trials, post-marketing studies, and spontaneous reports.
- Prepare safety information for Investigator Brochures, Informed Consent Forms, and other clinical trial documents.
- Act as a subject matter expert on pharmacovigilance regulations and guidelines (e.g., FDA, EMA).
- Respond to regulatory authority inquiries regarding product safety.
- Mentor junior scientists and contribute to the development of the pharmacovigilance team.
- Ensure compliance with all applicable pharmacovigilance regulations and company policies.
- Advanced degree (MSc, PhD, PharmD, MD) in a life science, pharmacy, medicine, or related field.
- Minimum of 7-10 years of progressive experience in pharmacovigilance within the pharmaceutical industry.
- In-depth knowledge of global pharmacovigilance regulations and guidelines.
- Proven experience in signal detection, risk assessment, and regulatory reporting.
- Strong scientific writing and communication skills, with the ability to clearly articulate complex safety information.
- Experience with safety databases and data analysis tools is essential.
- Excellent analytical and critical thinking abilities.
- Ability to work effectively in a hybrid environment, collaborating with colleagues both in the office and remotely.
- Demonstrated leadership potential and the ability to influence decision-making.
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