Pharmacovigilance - Director
Proclinical is currently recruiting for a Pharmacovigilance Director with a global pharmaceutical company located in Cambridge, MA. Successful candidate will support developmental programs, including both early and late stage development as required. Candidate will additionally 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.
- Company-wide 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 on 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 on 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 set-up of safety procedures and development of safety exchange agreements for co-development projects.
Skills and Requirements:
- 8+ years' experience in pharmacovigilance, clinical research or clinical development.
- 2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine.
- 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.
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 Nicole Aganon at (+1) 347-293-1161 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.
Proclinical Staffing is an equal opportunity employer.