Senior Medical Safety Director, Pharmacovigilance
ProClinical, in support of our client, are seeking an individual to fill the role of Senior Medical Safety Director of Pharmacovigilance, based in Waltham, MA. The successful candidate will oversee the assessment of medical safety information. Additionally, the incumbent will perform signal detection and benefit/risk management activities and contribute to the development of pharmacovigilance strategies for monitoring the safety profile of the company's products.
- Manage the Medical Drug Safety team within the Pharmacovigilance organization.
- Identify system and resource needs to ensure compliant medical safety evaluation processes.
- Oversee risk management and benefit-risk evaluation for clinical and post marketing programs.
- Lead development and maintenance of general safety signal management methodologies and product specific signaling strategies.
- Lead aggregate safety data reviews and the preparation of the medical content of periodic reports.
- Ensure safety profiles of relevant products are accurately and consistently represented in relevant labeling documents, identify and lead updates as required.
- Lead the preparation and delivery of compliant safety information for regulatory.
- Oversee the development of relevant medical sections of responses to safety-related health authority requests and various clinical documents.
- Organize and conduct quarterly Medical Safety Board meetings to review aggregate safety information and signal management for all products.
- Lead regular and ad-hoc cross functional safety review teams.
- Oversee and contribute to the preparation of safety reviews at Joint Safety Oversight Committee(s) for products developed and/or commercialized with external partners.
- Oversee medical review of individual case safety reports.
- Educate pharmacovigilance colleagues and others on medical assessment, signal detection and safety risk management practices.
- Identify opportunities and manage continuous improvement initiatives.
- Actively interact with external customers and service providers.
- Lead or contribute to the development and/or updates of relevant procedural documents.
- Provide medical safety expertise for internal and external audits and regulatory authority inspections for Pharmacovigilance.
- Maintain up-to-date working knowledge of applicable regulatory requirements, guidelines, and industry standards globally.
- Lead and influence decision making around multifaceted issues involving medical safety.
- Represent pharmacovigilance on other multi-departmental projects.
Skills And Qualifications
- MD and 7-10+ years of relevant experience in pharmacovigilance, including safety signal management and benefit-risk assessment.
- 2+ years of experience in clinical practice or in academic medicine.
- US Board Certified or eligible preferred
- Experience in global drug development in a relevant field.
- Experience authoring medical evaluations and contributing to regulatory submissions.
- Strong competency in disease mechanisms and medical therapies.
- Excellent written, verbal, and interpersonal communication skills.
- Proficiency in Microsoft Office and cloud-based 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 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.