Medical Director M-SERM

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as a Medical Director M-SERM

• And lead our efforts in medical safety evaluation and risk management. What You’ll Do:
• Maintain understanding of methods for recording time spent on project and administrative tasks, expense submissions and travel.
• Ensure tasks delegated to PV are properly executed. Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adhere to client SOPs/directives and project specific WPDs for assigned projects. Adhere to CRG’s corporate policies and SOPs/WPDs.
• Provide medical consultation to team members and answer all project/study related medical questions. Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provide safety reporting training on assigned projects/studies, as requested.
• Medically reviews adverse events and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.
• Provide medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported in Clinical Trials.
• Perform data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.
• Assist in writing (interpretation of safety data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.
• Manage signal detection activities, scientifically review periodic safety reports, contributes to label updates, supports dossier maintenance and risk management activities. Education and Experience: MD or equivalent required. History of an active medical license is highly preferred. Candidates should have at least one of the following:
• Clinical experience in having direct responsibility for diagnostic and treatment decisions (comparable to 2 years); Or
• Direct experience in medical review and assessment of safety information/Pharmacovigilance (comparable to 3 years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:
• Fluent in spoken and written English
• General medical knowledge of diagnostic and therapeutic approaches across multiple specialties. Therapeutic expertise across one or more medical specialties or sub-specialties preferred
• Strong decision-making, problem solving, organizational skills and analytical skills
• Excellent oral and written communication skills
• Excellent interpersonal skills
• Working knowledge of guidelines (FDA, ICH, EMA and GCP)
• Understanding of basic biostatistics, data management, and clinical operations procedures
• Excellent organizational skills
• Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
• Working knowledge of the drug development process and thorough understanding of guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
• Working knowledge of clinical program and study design, relevant endpoints, safety considerations, and current regulatory and commercial landscape.
• Working knowledge of marketed products pharmacovigilance regulations
• Working knowledge of Drug Safety Dictionaries (e.g. MedDRA)
• Working knowledge of relevant safety databases (e.g. ARGUS, ARISg)
• Ability to act as a mentor/trainer to entry level staff within the Pharmacovigilance Department
• Flexibility to travel domestically and internationally
• Proficiency in basic computer applications
• Ability to serve as a group liaison with other CRG groups and clients