Senior PV Physician Manager (remote-based)
Hobson Prior are working with a leading drug research and development organisation focused on providing new treatments for diseases that are mistreated. Our client is looking for a Senior PV Physician Manager to work remotely in either the UK or Germany where you will provide support to the Global Pharmacovigilance function.
- You will be the subject matter expert in interpretation of regulatory aspects of clinical safety/pharmacovigilance.
- Support the function Head in training and mentoring PV team colleagues including on interpretation of clinical safety data and analysis preparation and safety risk management activities.
- Subject matter expert in clinical safety data interpretation, clinical safety analysis preparation/benefit/risk assessment within periodic safety update reports or subject matter expert in signal detection activities, safety risk management activities, and safety profile/safety reference information maintenance.
- Support the function Head in overall activity planning and budget preparation.
- Medical review performance and contribution to serious adverse events/other Individual Case Safety Reports narratives preparation and assessment.
- Preparation of study-specific safety management plans (SMP; defining roles and responsibilities of each party involved in clinical safety data flow/ processes, templates, and timelines; using SMP template).
- Review of safety cases line listing and periodic safety reports and contribution to study-specific periodic progress reports.
- Contribution to study -specific PV training materials and safety-related sections of study documents together with other PV team members and in collaboration with clinical team members.
- Contribution to the preparation/update of PV standard operating procedures, working instructions, and templates.
- Any other tasks assigned.
- Ability to work effectively in a team environment and matrix structure.
- Very good knowledge of Microsoft Word, Excel, PowerPoint.
- Medical Doctor degree.
- You will have over 8 years in a Senior role.
- Minimum 8 years' clinical development experience in which at least 6 years' demonstrated experience working in clinical safety (within pharmaceutical companies, non-profit organizations or services providers).
- Experience of working in public and private sector is highly desirable.
- Fluency in English (proficiency in French and/or Spanish would be admirable).
- MedDRA coding and WHO-DD coding knowledge.
- Previous experience in HIV, HCV and/or tropical/infectious diseases would be welcome.
- Eudravigilance user or XEVMPD certification would be a plus.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
£80000 - £85000 per annum
Hobson Prior are looking for a Safety Science Director to join a leading pharmaceutical organisation who are focused on researching
€145000 - €150000 per annum
Hobson Prior are working with a world-wide pharmaceutical organisation who have improved the lives of countless patients.