Associate Director, Safety Scientist

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
 

We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
 

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness

• ​Financial Wellness

• Support for Caregivers
   

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
 

The Importance of the Role

The Safety Scientist will join the Global Pharmacovigilance (GPV) department and support risk management, safety reporting and quality management activities under the direct guidance of a Safety Physician. The Safety Scientist will represent GPV in cross-functional teams and meetings, to monitor and evaluate safety information while minimizing the risk of assigned products.

The Opportunity to Make a Difference

• Support risk management activities by requesting, gathering, consolidating, performing preliminary analysis, and preparing safety data for integration into risk management plans, product labeling, investigational brochures, and Development/Company Core Safety Information.
• Support routine signal detection, signal analysis, and maintenance of signal management tracker by requesting, gathering, consolidating, performing preliminary analysis, preparing safety data, and creating presentations for safety governance meetings.
• Participate and contribute to discussions in cross-functional safety governance forums by preparing presentations and providing input/answers during discussions.
• Participate in investigations of potential drug-related adverse events.
• Provide data analysis of adverse events, safety concerns, and other safety information beyond routine signaling including but not limited to medical information requests, regulatory submissions, safety-related sections of clinical trial documents, health agency queries and product complaints.
• Facilitate timely presentation of pertinent issues to GPV governance for escalation and/or information from weekly case review and clinical trial team meetings.
• Participate in medical safety oversight of clinical trials and contributes to protocol development, safety data evaluation, statistical analysis plans, and clinical study reports.
• Participate in medical review of individual case safety reports and periodic safety reports.
• Contribute (provide content/initial drafts, interpretation, and review) to the safety evaluation and risk management sections of periodic reports for assigned products.
• Contribute to the development of interdepartmental processes and procedures

More about You

• Healthcare degree in Medicine, Biological Sciences, Nursing, or Pharmacy
• 3 to 5 years of risk management and safety reporting experience in Drug Safety / Pharmacovigilance
• Experience in participating in signal management and risk management governance teams
• Familiarity with Pharmacovigilance and Risk Management regulations and guidelines including Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
• Working knowledge of MedDRA, MedDRA SMQs, and Safety Databases (preferably Argus)
• Familiarity with safety reviews of clinical and post marketing safety data/documents, and working with IBs, study protocols, clinical study reports, informed consent forms and safety submissions
• Good written and verbal communication skills including ability to interpret data and communicate key concepts to global cross-functional counterparts
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