Associate Medical Director, Pharmacovigilance
Proclinical is currently recruiting for an Associate Medical Director of Pharmacovigilance with a pharmaceutical company located in Boston, MA. Successful candidate will be responsible for the 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.
- 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.
- Support Therapeutic Lead.
- Line management responsibilities for junior physicians and/or scientists.
- Serve in a leadership capacity for complex and strategically important programs.
- Review and oversight of safety data, both non-clinical and clinical.
- Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities.
- Review of safety data and participate in dose escalation decisions.
- Authorship and sign off of 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.
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities.
Skills and Requirements:
- Qualified physician (License, e.g. GMC registered, preferred).
- Minimum of 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.
- 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 Kevin Hansberry at (+44) 207 4400 636 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.