ProClinical is currently supporting one of the leading Pharmaceutical clients based in Boston, MA who is seeking an experienced Pharmacovigilance Physician to join them as Medical Director, Pharmacovigilance. This is a newly created global role focusing within the Gastrointestinal therapeutic area.
- Support developmental programs, including both early and late stage development as required.
- 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.
- 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
- Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
- Qualified physician
- Considerable experience in pharmacovigilance, clinical research or clinical development
- Moderate clinical experience with patients following post-graduate training with significant knowledge of general medicine
- Knowledge of principles of epidemiology and statistics.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Anna Graham on +1 646 542 0152 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.