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Safety Surveillance and Medical Affairs Lead

3 months ago

Hertfordshire, United Kingdom Hobson Prior Full time
Position Overview

Hobson Prior is in search of a Safety Surveillance and Medical Affairs Lead to direct and oversee a robust Pharmacovigilance framework. This position entails leading a dedicated team, ensuring the safety of our pharmaceutical products, and maintaining adherence to regulatory standards.

Essential Duties

1. Develop, manage, and uphold a compliant Pharmacovigilance framework.

2. Supervise the daily operations of the Pharmacovigilance and Medical Affairs Team.

3. Assess the safety profile of our pharmaceutical products and conduct ongoing evaluations during the post-marketing phase.

4. Manage Individual Case Safety Reports, Standard Operating Procedures, and the preparation of aggregate safety reports and Safety Data Exchange Agreements.

5. Serve as a subject matter authority on Risk Management Plans, Post Authorization Safety Study protocols, Risk Minimization Strategies, and the effectiveness of follow-up actions.

Qualifications

1. Proven experience in the pharmaceutical or pharmacovigilance sector, with a background in team leadership.

2. A degree or equivalent qualification in medicine or life sciences, or relevant experience (e.g., Physician, Pharmacist, Nurse).

3. Comprehensive understanding of national and regional regulatory frameworks and guidelines.

4. Familiarity with pharmacovigilance regulations in the UK, Europe, and Australia is essential; knowledge of additional international markets is advantageous.

5. Proficient in team management, including oversight of outsourced vendor activities within a compliance-driven environment.

Next Steps

If you are keen to explore this opportunity further, please submit your CV. For additional information or to engage directly with a life sciences recruitment expert, please reach out through the provided contact options.

Hobson Prior is a premier life sciences recruitment agency dedicated to connecting exceptional talent with outstanding career opportunities worldwide. Hobson Prior operates as an Employment Agency concerning this position.

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