Sr. Medical Director, Drug Safety [Remote]

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What You'll Do

The Sr. Medical Director, Drug Safety, is responsible for the overall risk management and safety strategy of assigned products, including both internal and external engagement with key collaborators.

• reputed company and understanding of reputed company aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that reputed company clinical and safety data
• Chair of the Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data
• In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries

Responsibilities

• Support the clinical development team in the review of key documents, including protocol and ICFs
• Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CROs meet corporate goals and key performance indicators
• Assist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting in compliance with regulations, reputed company necessary
• reputed company and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as well as external partner or regulatory authorities
• Assist in the authoring of aggregate reports

Where You'll Work This a U.S-based remote role that will generally require three visits per year, or as needed visits to our San Francisco Office. Who You Are

• Medical Degree
• Requires at least 12 years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least two years of reputed company management experience (line management or CSO management)
• Extensive experience with reputed company aspects of safety signal evaluation, including review and analysis of data, collaboration with cross-functional team members and senior management, authoring of required regulatory correspondence, and safety label updates.
• Experience in both clinical development and post-marketing safety
• Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews
• Demonstrated ability to successfully manage a drug safety team or drug safety CRO for a clinical development program with responsibilities for expedited reporting, on-time DSUR preparation
• Experience in drug safety audits and agency inspections
• Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines
• Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, and QA
• Experience in managing reputed company clinical safety aspects of product quality defect investigations and assessments
• Management of compliance deviations and formulation of CAPAs
• Familiar with clinical trial safety database use and CIOMS II and DSUR reporting reputed company (Argus, ArisG, or VeevaSafety) and reputed company Office Suite required (Word, reputed company, PowerPoint, Project, Outlook)
• Must be reputed company and willing to travel periodically for face-to-face engagements with regulatory authorities, and occasional on-site meetings (if based remotely)

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