Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data
Facilitate 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
Support the clinical development team in the review of key documents, including protocols and informed consent forms (ICFs)
Manage drug safety contract research organizations (CROs) for clinical programs to ensure compliance with expedited reporting requirements, on-time and scientifically sound DSUR preparation, and alignment with corporate goals and KPIs
Assist in the medical review of adverse event reports; manage preparation and submission of expedited safety reports in compliance with global regulations, when necessary
Develop and prepare assessments of safety data, safety signals, and benefit-risk evaluations for internal senior management as well as external partners and regulatory authorities
Assist in the authoring of aggregate safety reports

Requirements

Bachelor’s degree in a healthcare discipline or equivalent is required; an advanced degree is preferred
Minimum of ten years of drug safety and pharmacovigilance experience, including at least five years in clinical development safety
Extensive experience with all aspects of safety signal evaluation, including data review and analysis, cross-functional collaboration, authoring 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 global regulatory reviews is highly preferred
Experience in drug safety audits and regulatory agency inspections
Intimate knowledge of GCP and strong working knowledge of FDA regulations, ICH guidelines, and global pharmacovigilance requirements
Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitoring, clinical operations, biostatistics, regulatory affairs, medical writing, and quality assurance
Experience managing clinical safety aspects of product quality defect investigations and assessments
Familiarity with clinical trial safety databases and CIOMS II and DSUR reporting (e.g., Argus, ArisG, or Veeva Safety) and proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook)

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

drug safetypharmacovigilancesafety signal evaluationdata reviewregulatory submissionsGCPFDA regulationsICH guidelinesclinical safety managementsafety data analysis

Soft Skills

collaborationcommunicationleadershiporganizational skillsproblem-solvingattention to detailanalytical thinkingstrategic planninginterpersonal skillsproject management