A leading global Pharmaceutical client based in Boston, MA, is seeking an experienced Pharmacovigilance professional for an Associate Director level position.
Working in a global team you will be responsible for supporting products in development as well as commercialised.
- Oversight of signal detection and risk management activities for designated global products together with usual safety mandated remit.
- Direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs etc.
- Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
- Medical Degree required or internationally recognized equivalent.
- 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.