Medical Director, Safety Evaluation & Risk Management
Proclinical is currently recruiting for a Medical Director of Safety Evaluation and Risk Management for a global pharmaceutical company located in Waltham, MA. Successful candidate will play a key role in supporting the Central Safety Leadership Team and the broader business at both a strategic and operational level.
- Provide high level medical expertise in the safety evaluation and risk management of key assets or other highly complex products in clinical development and/or the post-marketing setting.
- Ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labeling updates and drive proactive implementation of risk management initiatives.
- Have a proven ability to lead safety evaluation activities, ensure that appropriate safety objectives and risk minimization strategies are included in clinical development programs and shows confidence, credibility and influence at all levels of the organization.
- Review and provide technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters.
- May lead or participate in discussion at Global Safety Board for safety related findings in clinical development.
- Present safety information at clinical investigator and commercial meetings.
- Ensure prompt notification to Group Leader or above of reviewed protocols that are identified as potential PASS
- Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labeling, as appropriate.
- Provide medical expertise for risk evaluation and risk management planning.
- Drives signal detection for assigned products using available methodologies (including On-Line Signal Management tool, literature review and tools for individual case awareness).
- Conduct proactive signal detection and evaluation of issues potentially related to product defects or manufacturing issues; drives the escalation and resolution of issues and product complaints.
- Drive production of periodic regulatory documents (PBRERs, Annual Reports) according to the agreed process and timelines.
- Lead the Pharma Safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts.
Skills and Requirements:
- Physician (M.D. or equivalent) ideally with board certification in Internal Medicine, Family Medicine, Emergency Medicine or Surgery. Subspecialty training/certification is a plus. Active or eligibility for a US Medical license is required.
- In depth oncology or immunology experience.
- Expert evaluation skills and analytical thinking.
- Outstanding medical writing skills.
- Previous experience in clinical practice.
- Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to Pharma Safety activities.
- Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education.
- Sound knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level.
- In depth knowledge of medical and drug terminology and a sound foundation in pharmacology. Good medical judgement and ability to make medical decisions.
- Clear understanding of clinical development process.
- Clear understanding of drug approval process in major countries.
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 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.
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