Hobson Prior is currently recruiting for a Medical Director (Pharmacovigilance) based in London. The position is with a large pharmaceutical company and will need someone who has had experience in a global PV environment. This role will entail supporting developmental programs, including both early and late stage development.
- Expectation of GSL role for compound both in development and marketed in close partnership with the TAL.
- Provide knowledge of safety, including any emerging safety concerns and risk/benefit profile your compounds with input for other compounds as needed.
- Serving in a leadership capacity for complex and strategically important programs.
- Accountable for the development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds.
- Responsible for training and mentoring Pharmacovigilance Physicians and Specialists.
- You will review and oversight safety data, both non-clinical and clinical and participate in dose escalation decisions.
- You will be companywide safety expert for his/her compound responsibilities.
- Review and/or sign off protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities.
- Authorship and sign off 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.
- Manage the setup of safety procedures and development of safety exchange agreements for co-development projects.
- Critical thinking and analytical skills and ability to make high level decisions.
- Strong oral and written communication skills including the ability to present to large internal/external groups.
- Good level of computer literacy with Microsoft applications.
- Qualified Physician (Licence, e.g. GMC registered, preferred).
- A minimum of 10+ years as a Drug Safety Physician.
- Extensive experience in global pharmacovigilance, clinical research or clinical development.
- Previously have written and medically reviewed PSURs.
- Knowledge of principles of epidemiology and statistics.
- 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 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.