Senior Medical Director - PV
Proclinical is currently recruiting for a Senior Medical Director of Pharmacovigilance with a global pharmaceutical company located in Boston, MA. Successful candidate will be responsible for the leadership and oversight of a therapeutic area and management of physicians who serve as the Global Safety Leaders (GSL) for both developmental and marketed compounds in designated therapeutic area.
- Interact with and influence other TDC departments (Clinical Operations, Regulatory affairs, Analytical Science, Clinical Science, etc.) to ensure the successful development, design and implementation of comprehensive safety assessment protocols for both developmental and marketed products.
- Oversee signal detection and risk management activities in the assigned therapeutic area and ensure that development plans include comprehensive safety assessment plans.
- Lead and direct the interpretation of safety data from internal and external studies. To communicates at senior leadership level the impact of such data in terms of "go/no go" decisions or modification of development plans and/or study designs and the associated impact on timelines and/or labelling.
- Responsible for reviewing, analyzing and interpreting information from ongoing clinical and non-clinical studies alongside the assessment of ensuing scientific and medical implications and making recommendations based on new safety information for both developmental compounds and marketed drugs to ensure the primacy of patient safety.
- Participate with colleagues in other Global Safety Functions in the development of a global consensus on signal detection tools and activities.
- Support cross functional (within and outside Global PV) team evaluations in preparation for Safety Board presentations as well as having the leadership role for assigned products in safety data presentations to Safety-Board.
- Attend corporate committees such as the Therapeutic Area Teams and Development Review Committee representing the assigned therapeutic area(s).
- Oversee the medical safety evaluation of projects by the PV physicians for new business development opportunities (e.g., due diligence evaluations).
- Direct PV interactions with Regulatory authorities.
- Anticipate regulatory implications of emerging safety issues and develop strategies for handling/managing such issues.
- Oversee risk management plans for compounds in development and market drugs.
- Ensure that PV physicians are proactively identifying safety concerns and developing contingency strategies that address these challenges.
- Manage PV physicians in the preparation, analysis, and presentation of safety information.
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities.
Skills and Requirements:
- Qualified physician (License/ registered, preferred).
- 8+ years of 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 Divya Mistry at (+1) 646-630-9650 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.