ProClinical are currently supporting a Biotechnology client based in New Jersey, who are focused in the Rare Disease / Orphan Drug space, who are currently seeking a Senior Medical Director, Pharmacovigilance to join them on a permanent basis. This is a newly created position and a highly visible role where you would be involved in strategic management of the group, supporting products in development as well as commercialized on a global basis.
- Provide detailed, accurate and timely medical review of aggregate and/or individual clinical trial and post-marketing adverse event reports (AERs)
- Medically review individual case study reports from clinical trials, as well as evaluate all relevant cases in depth, including MedDRA coding
- Perform regulatory assessment for expectedness and seriousness of AEs
- Compose, review and deliver Periodic Adverse Drug Experience Reports
Skills and Requirements:
- M.D. degree required, with requisite pharmaceutical Drug Safety and Pharmacovigilance experience in both the pre- and post-marketing settings.
- M.D. degree required with 8-10 years of pharmaceutical Drug Safety and Pharmacovigilance experience in both the pre- and post-marketing settings.
- Strong leadership skills, as well as experience working in a matrix environment.
- Must be experienced in safety reviews of IBs, protocols, interim and final clinical study reports, and summaries of safety, both for agents under development, as well as marketed products
- Must have strong working knowledge of FDA and EMA regulations/ICH guidelines.
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 Resume 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.