The Drug Safety Manager will have primary responsibility for the following, providing end‑to‑end safety leadership across clinical studies and marketed products.
Clinical Study Safety Management & Planning
- Serve as the PV Safety Program Lead for assigned clinical studies, with end‑to‑end accountability for safety oversight from study startup through closeout.
- Ensure study‑specific Safety Management Plans (SMPs) are developed, approved, implemented, and maintained in accordance with ICH guidelines, regulatory requirements, and Alkermes SOPs.
- Ensure all required safety forms, templates, and documentation are in place and aligned across systems and vendors, including but not limited to SAE and pregnancy reporting forms, narrative templates, IND safety report cover letters, fax cover sheets, and study‑specific safety documentation.
- Review protocols, protocol amendments, and protocol update request forms for safety accuracy, completeness, and regulatory compliance.
- Act as the PV representative on clinical project teams, ensuring safety considerations are integrated into study conduct, risk management, and decision‑making.
Case Processing, Reporting & Compliance
- Responsible for the receipt, evaluation, review, coding, follow‑up, and reporting of adverse event (AE) information for marketed and investigational products in compliance with ICH guidelines, FDA, EMA, global regulatory requirements, Alkermes SOPs, and applicable licensing or partnership agreements.
- Track safety cases from receipt through closure, ensuring timely follow‑up, event resolution, and documentation of completeness.
- Apply clinical judgment in the medical review and coding of verbatim adverse events, medical history, and concomitant medications; synthesize complex clinical information into accurate and complete safety reports.
- Ensure SUSAR identification and submission compliance with applicable global regulatory requirements and internal procedures.
- Oversee and support SAE reconciliation, single‑case and end‑of‑study unblinding activities, deviation memo preparation, and deletion or administrative edit requests.
- Assist in the preparation and submission of regulatory safety deliverables, including IND safety reports, annual safety reports, PSURs, and clinical study reports.
- Contribute to ongoing safety surveillance for marketed and investigational products, including identification and evaluation of events of special interest and participation in aggregate data review.
Vendor and CRO Oversight
- Provide day‑to‑day PV oversight of CROs and vendors supporting clinical safety activities to ensure timelines are met, issues are proactively communicated, and resolutions are timely and documented.
- Collaborate with vendors to ensure appropriate staffing, study setup, training, and ongoing performance monitoring, while maintaining clear separation between sponsor oversight and vendor execution.
- Provide input into vendor and CRO selection and evaluation, including assessment of safety capabilities, experience, and inspection readiness.
- Act as a safety liaison between external reporting sources (e.g., investigator sites, call centers, CROs) and internal stakeholders, including Clinical Operations, Medical Information, Regulatory Affairs, Quality Assurance, Biostatistics, Data Management, Product Development, and Legal.
Systems, Data Quality & Configuration
- Ensure appropriate study configuration in the global safety database, including study parameters, workflows, and reporting rules.
- Review relevant eCRF forms to confirm alignment with safety forms and to support accurate AE and SAE reconciliation.
- Conduct interim coding reviews of adverse events and concomitant medications in accordance with study‑specific plans.
- Ensure registration and maintenance of regulatory reporting systems (e.g., EudraVigilance), as required.
Metrics, Quality & Continuous Improvement
- Collaborate with case processing teams to develop, track, and report metrics related to clinical trial SAE processing, vendor performance, and compliance.
- Lead and support continuous quality improvement initiatives, ensuring data consistency, high‑quality safety outputs, and process efficiency across products and studies.
- Identify trends, risks, and improvement opportunities and escalate appropriately through safety governance channels.
- Lead implementation of process improvements, issue management, and CAPAs related to safety case processing and study oversight.
Documentation, SOPs & Inspection Readiness
- Ensure all safety‑related documentation is complete, accurate, and inspection‑ready, and appropriately filed in the TMF and safety files.
- Author, review, and contribute to SOPs, work instructions, and guidance documents, including development and maintenance of Safety Management Plans.
- Serve as a subject matter expert (SME) for audits, inspections, internal reviews, and health authority queries, providing clear safety oversight rationale and documentation.
Leadership & Additional Responsibilities
- Demonstrate accountability, ownership, and a sense of urgency in leading and managing safety‑related projects.
- Willingness to both manage and directly support case processing activities as business needs require.
- Perform other duties as assigned, consistent with the scope and accountability of the role.
