Position Responsibilities:
- Designs, produces and oversees protocols for observational studies using secondary data or primary data collection, including Company-sponsored or other data sources
- Oversee timely and appropriate development of epidemiological sections of regulatory documents for agencies worldwide (e.g., Risk Management Plan, orphan or breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing documents
- Contributes to Risk Management Plans (RMP, PV Plans etc) for products throughout lifecycle
- Performs systematic epidemiologic literature reviews and summaries for relevant safety topics
- Performs signal detection analyses of safety reporting system databases (AERS, Vigibase) using data mining software
- Actively participates including making presentations at meetings including product safety team and Global Patient Safety staff meetings
- May supervise 3rd parties e.g., vendors or contract/other staff
- Supports PV System implementation and maintenance and other Departmental goals and objectives
Candidate Requirements:
- Doctoral degree e.g., PhD or Master’s degree in Epidemiology from an accredited institution
- Minimum of 10 years relevant work experience, preferentially in the Pharmaceutical/Biotechnology industry with a primary focus on epidemiology evidence generation, especially for clinical development support, regulatory submissions and safety
- Solid knowledge of study methodology in general medicine and clinical practice, evidenced by experience in designing/conducting epidemiology studies, including Registries
- Strong knowledge and experience in Global Pharmacovigilance guidelines, Risk Management and regulations; knowledge of international PV regulations is a plus
- Experience with data mining software and applications
- Demonstrated ability to function with a high level of autonomy and develop productive cross-functional collaborations.
- Ability to manage priorities, resources, and performance targets, in a changing environment.
- Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions.
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What We Do
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn. For additional information on our guidelines, please visit https://scholarrock.com/community-guidelines/ For more information on how Scholar Rock collects, uses, and shares personal information, please visit: https://scholarrock.com/privacy-policy
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