Medical Director, Pharmacovigilance

Medical Director, Pharmacovigilance
Location: Metro-Boston West

Job Description:

The Medical Director, Pharmacovigilance (PV) will assist the Senior Director of PV in the medically- and scientifically-related services needed to accomplish good Pharmacovigilance practice for Company products in development and commercialization, and may be assigned to some or all of the following named responsibilities as determined by the Senior Director:

• Developing pharmacovigilance plans for planned or ongoing clinical studies;
• Managing safety reporting activities outsourced to CROs or other service providers;
• Working closely with project and study teams to ensure that PV needs are addressed;
• Maintaining a comprehensive safety signaling program for delegated Company products;
• Developing, implementing, and maintaining pre- and post-approval product-specific risk management plans;
• Assisting with the development and critical review of various product documents (e.g., investigator brochures, protocols, core data sheets);
• Participating in the development and monitoring of registry or epidemiologic studies associated with approved products;
• Serving as product safety expert on assigned teams (e.g., product labeling committees);
• Performing medical review of individual case safety reports; • Analyzing aggregate safety data for periodic report (e.g., PSUR) preparation, internal clinical safety review, and preparation of ad hoc reports such as regulatory authority response documents;
• Tracking and trending safety issues being monitored and maintaining appropriate documentation of activities and findings;
• Formulating and implementing SOPs, process flow maps, and other quality documents.

Required Skills:
• Education: MD degree with clinical practice experience (primary care or internal medicine subspecialty preferred).
• Excellent interpersonal skills and communication skills, including oral presentation and technical manuscript writing
• Competence with technology applications including commercial safety databases
• Ability to work effectively as an individual contributor and as project team member; collaborative spirit
• Thorough understanding of the regulatory environment for pharmacovigilance, with working knowledge of worldwide regulations and guidelines
• Demonstrated record of incisive problem-solving
• Ability to analyze and interpret complex and multivariate safety issues
• Ability to understand and apply biostatistics and epidemiology methodology
• Effective project management skills; ability to prioritize workload and work effectively, sometimes within resource constraints
• Ability to recruit and manage external consultants as needed
• Demonstrated ability to provide critical and timely insight
• Familiarity with industry principles of drug development, pharmacology and toxicology

Required Experience:
• A minimum of 3 years experience within the pharmaceutical industry, with the most recent 2 years within a global drug safety/pharmacovigilance department is required
• 2+ years of experience with safety signaling, assessment of drug risks and benefits, and safety assessment of marketed drugs and those in development is strongly preferred
• Epidemiology training with related field experience is strongly preferred

Company Presentation: 

The company is recognized as one of the 500 fastest growing technology companies in US and as one of the 100 best places to work in MA. The company is a Biopharmaceutical company developing pharmaceuticals of unmet medical needs with research and development in MA, and is a public company trading in NASDAQ with nearly 600 employees.