Hobson Prior is working with a leading global pharmaceutical company has a new vacancy for a Medical Director, PVG to join their expanding Central London team. The company has a superb pipeline and operates in over 90 countries around the world.
The Medical Director will support developmental programs, including both early and late stage development as required. They role will also be responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly as appropriate.
- Expectation of GSL role for compound(s) both in development and marketed in close association with the TAL.
- Companywide safety expert for his/her compound responsibilities
- Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for own compounds with input for other compounds as needed.
- Serving in a leadership capacity for complex and strategically important programs
- Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc
- Training and mentoring of Pharmacovigilance Physicians and Specialists
- Perform activities required to serve as Global PV physician:
- Review and oversight of safety data, both non-clinical and clinical
- Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
- Interactions with external experts and regulatory agencies and partner/co-development companies
- Review of safety data and participate in dose escalation decisions
- Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
- Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
- Direct the setup of safety procedures and development of safety exchange agreements for co-development projects
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities
- Qualified physician (Licence, e.g. GMC registered, preferred)
- Knowledge of principles of epidemiology and statistics.
- Critical thinking and analytical skills and ability to make high level decisions
- Excellent oral and written communication skills including ability to present to large internal/external groups-Good level of computer literacy with Microsoft applications
- Extensive experience in pharmacovigilance, clinical research or clinical development
- Clinical experience with patients following post-graduate training with significant knowledge of general medicine
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life science recruiter focussed 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.