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Associate Director, Safety Scientist

Company: Sarepta Therapeutics
Location: Somerville
Posted on: June 13, 2022

Job Description:

Scientist with experience and expertise in Pharmacovigilance Risk Management, Safety Reporting and Quality Management. The incumbent 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 incumbent will represent GPV in cross-functional teams and meetings.Primary Responsibilities include:Risk ManagementSupport 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.Safety ReportingParticipate 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.Quality ManagementContribute to the development of interdepartmental processes and proceduresEducation and Skills Requirements:--- - - -Advanced degree in Biological Sciences, Nursing, or Healthcare Administration--- - - -10+ years of risk management and safety reporting experience in Drug Safety / Pharmacovigilance--- - - -Experience 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 Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)--- - - -Working knowledge of MedDRA, MedDRA SMQs, and Safety Databases (preferably Argus and ArisG)--- - - -Familiarity with safety reviews of clinical and post marketing safety data/documents--- - - -Good written and verbal communication skills including ability to interpret data and communicate key concepts to global cross-functional counterparts--- - - -Ability to actively contribute to continual process improvement initiatives and enhance the knowledge and skill set of peers and fellow employees--- - - -Ability to effectively represent department in internal cross-functional meetings--- - - -Recognized by former peers, colleagues, managers, and direct reports for attributes congruent with Sarepta Values: -Drive, Excellence, Resilience, Teamwork, Innovation and CompassionCandidates must be authorized to work in the U.S. -Sarepta Therapeutics offers a competitive compensation and benefit package. -Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.SummaryLocation: Cambridge, MAType: Full time

Keywords: Sarepta Therapeutics, Somerville , Associate Director, Safety Scientist, Executive , Somerville, Massachusetts

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