Senior Medical Director, Drug Safety and Pharmacovigilance
Proclinical is currently recruiting for a Senior Medical Director of Drug Safety and Pharmacovigilance (DSPV) with a biopharmaceutical company located in Waltham, MA. Successful candidate will serve as the therapeutic area lead for all investigational and/or marketed CNS products in pharmacovigilance and risk management activities.
- Serve as the therapeutic area lead for all investigational and/or marketed CNS products in pharmacovigilance and risk management activities.
- Accountable for the strategic safety oversight of all company CNS products as well as the management, mentoring and development of assigned benefit-risk management staff.
- Serve as a global safety officer for one or more assigned investigational and/or marketed products.
- Provide safety leadership and advisement in a number of company-wide forums and initiatives.
- Lead/oversee CNS product safety strategy, surveillance, and signaling activities in collaboration with DSPV staff.
- Acquire a deep understanding of the disease process and assigned product(s) efficacy and safety profile including a working knowledge of other products in the class and therapeutic space.
- Ensure development and implementation of other department goals, policies and strategies in collaboration with the DSPV management team, consistent with regulatory requirements and industry best practices.
- Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities.
- Ensure that routine signaling activities, assessment and investigation are completed and documented in a timely manner.
- Respond to product safety queries from all sources including ethics committees and regulatory authorities.
- Build high trust, accountability and demonstrate a sense of urgency in leading critical projects, show the capability to work either independently or collaboratively and be able to effectively communicate with varied stakeholders both verbally and in writing.
- Interact with multiple levels of management, external stakeholders in the medical community as well with global regulatory authorities.
- Oversee safety officers who are responsible for identification of safety signals, signal investigation and the proactive management of the benefit-risk profile for assigned products, the therapeutic area lead plays a critical leadership role in to program team through the product life-cycle working in close collaboration with Research, Pre-clinical Safety, Clinical Development, Medical Affairs, Regulatory Affairs and other functions in product life-cycle management.
Skills and Requirements:
- MD, or MD PhD, or MD MPH required.
- Minimum of 7-years of experience in drug safety, with experience in CNS.
- Minimum of at least 1 year experience in managing direct reports.
- High EQ with a passion for Drug Safety and managing and developing direct reports as well as highly effective team.
- Prior experience in patient care, clinical development and/or knowledge of clinical pharmacology desirable.
- Demonstrated strategic and critical thinking skills.
- Demonstrated leadership as well as the ability to perform effectively in a matrixed and dynamic environment, ability to lead and collaborate within complex organization, across functions and geographies; to work in an entrepreneurial culture
- Excellent communication (oral and written) as well as organizational skills.
- Demonstrated sense of urgency and accountability for both individual and team-owned work products.
- Knowledge of pre- and post-marketing US and EU regulations.
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 Yannick Dada at (+1) 646-741-8433 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.