Drug Safety Program Manager
Alkermes
5 months ago
Remote friendly (Greater Boston)
United States
Operations
Responsibilities:
- Serve as PV Safety Program Lead for assigned clinical studies, with end-to-end accountability for safety oversight from study startup through closeout.
- Develop, approve, implement, and maintain study-specific Safety Management Plans (SMPs) in accordance with ICH guidelines, regulatory requirements, and Alkermes SOPs.
- Ensure required safety forms, templates, and documentation are in place and aligned across systems and vendors (e.g., SAE and pregnancy reporting forms, narrative templates, IND safety report cover letters, fax cover sheets).
- 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 to integrate safety considerations into study conduct, risk management, and decision-making.
- Receive, evaluate, review, code, follow up, and report adverse event (AE) information for marketed and investigational products in compliance with ICH/FDA/EMA and applicable requirements.
- Track safety cases through closure, ensuring timely follow-up, resolution, and documentation of completeness.
- Perform clinical judgment in medical review/coding of adverse events, medical history, and concomitant medications; produce accurate safety reports.
- Ensure SUSAR identification and submission compliance.
- Support SAE reconciliation, single-case and end-of-study unblinding activities, and related documentation (e.g., deviation memos; deletion/administrative edit requests).
- Assist in preparing and submitting regulatory safety deliverables (IND safety reports, annual safety reports, PSURs, clinical study reports).
- Contribute to ongoing safety surveillance, including events of special interest and aggregate data review.
- Provide day-to-day PV oversight of CROs and vendors supporting clinical safety activities.
- Collaborate on vendor staffing, study setup, training, and performance monitoring while maintaining sponsor oversight vs. vendor execution.
- Provide input into vendor/CRO selection and evaluation (safety capabilities, experience, inspection readiness).
- Act as a liaison between external reporting sources and internal stakeholders (Clinical Operations, Medical Information, Regulatory Affairs, QA, Biostatistics, Data Management, Product Development, Legal).
- Ensure study configuration in the global safety database and alignment of eCRF forms with safety forms.
- Conduct interim coding reviews and ensure regulatory reporting system registration/maintenance (e.g., EudraVigilance).
- Develop, track, and report safety/SAE processing metrics and vendor performance/compliance metrics.
- Lead/support continuous quality improvement, identify trends/risks, escalate appropriately, and implement process improvements/CAPAs.
- Ensure safety documentation is complete, accurate, inspection-ready, and filed in the TMF and safety files.
- Author/review SOPs and guidance documents; serve as SME for audits, inspections, internal reviews, and health authority queries.
- Demonstrate accountability and urgency; may directly support case processing as needed.
Qualifications:
- Minimum: Clinical degree (e.g., RPh/PharmD, BSN, RN); 5–7 years’ drug safety or clinical safety experience.
- Demonstrated general medical and pharmacology knowledge.
- Demonstrated knowledge of domestic and international regulatory safety reporting requirements (FDA/ICH pharmacovigilance; Good Clinical Practices).
- Ability to make clinical decisions and formulate appropriate queries based on medical knowledge.
- Preferred: Experience with commercial safety databases (Clintrace, ArisG, Argus); knowledge of clinical trial databases (e.g., Trailmaster) is a plus.
- Ability to work independently with minimal supervision; strong attention to detail and proactive multitasking.
- Strong problem-solving, interpersonal/communication, and organizational skills; ability to prioritize and work effectively under resource constraints.
Benefits/Compensation:
- Annual base salary: $145,000–$158,000; eligible for an annual performance pay bonus.
Work model:
- Hybrid role: 60% office / 40% home; at least 3 days per week onsite in Waltham, MA; not eligible for fully remote work.
- Serve as PV Safety Program Lead for assigned clinical studies, with end-to-end accountability for safety oversight from study startup through closeout.
- Develop, approve, implement, and maintain study-specific Safety Management Plans (SMPs) in accordance with ICH guidelines, regulatory requirements, and Alkermes SOPs.
- Ensure required safety forms, templates, and documentation are in place and aligned across systems and vendors (e.g., SAE and pregnancy reporting forms, narrative templates, IND safety report cover letters, fax cover sheets).
- 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 to integrate safety considerations into study conduct, risk management, and decision-making.
- Receive, evaluate, review, code, follow up, and report adverse event (AE) information for marketed and investigational products in compliance with ICH/FDA/EMA and applicable requirements.
- Track safety cases through closure, ensuring timely follow-up, resolution, and documentation of completeness.
- Perform clinical judgment in medical review/coding of adverse events, medical history, and concomitant medications; produce accurate safety reports.
- Ensure SUSAR identification and submission compliance.
- Support SAE reconciliation, single-case and end-of-study unblinding activities, and related documentation (e.g., deviation memos; deletion/administrative edit requests).
- Assist in preparing and submitting regulatory safety deliverables (IND safety reports, annual safety reports, PSURs, clinical study reports).
- Contribute to ongoing safety surveillance, including events of special interest and aggregate data review.
- Provide day-to-day PV oversight of CROs and vendors supporting clinical safety activities.
- Collaborate on vendor staffing, study setup, training, and performance monitoring while maintaining sponsor oversight vs. vendor execution.
- Provide input into vendor/CRO selection and evaluation (safety capabilities, experience, inspection readiness).
- Act as a liaison between external reporting sources and internal stakeholders (Clinical Operations, Medical Information, Regulatory Affairs, QA, Biostatistics, Data Management, Product Development, Legal).
- Ensure study configuration in the global safety database and alignment of eCRF forms with safety forms.
- Conduct interim coding reviews and ensure regulatory reporting system registration/maintenance (e.g., EudraVigilance).
- Develop, track, and report safety/SAE processing metrics and vendor performance/compliance metrics.
- Lead/support continuous quality improvement, identify trends/risks, escalate appropriately, and implement process improvements/CAPAs.
- Ensure safety documentation is complete, accurate, inspection-ready, and filed in the TMF and safety files.
- Author/review SOPs and guidance documents; serve as SME for audits, inspections, internal reviews, and health authority queries.
- Demonstrate accountability and urgency; may directly support case processing as needed.
Qualifications:
- Minimum: Clinical degree (e.g., RPh/PharmD, BSN, RN); 5–7 years’ drug safety or clinical safety experience.
- Demonstrated general medical and pharmacology knowledge.
- Demonstrated knowledge of domestic and international regulatory safety reporting requirements (FDA/ICH pharmacovigilance; Good Clinical Practices).
- Ability to make clinical decisions and formulate appropriate queries based on medical knowledge.
- Preferred: Experience with commercial safety databases (Clintrace, ArisG, Argus); knowledge of clinical trial databases (e.g., Trailmaster) is a plus.
- Ability to work independently with minimal supervision; strong attention to detail and proactive multitasking.
- Strong problem-solving, interpersonal/communication, and organizational skills; ability to prioritize and work effectively under resource constraints.
Benefits/Compensation:
- Annual base salary: $145,000–$158,000; eligible for an annual performance pay bonus.
Work model:
- Hybrid role: 60% office / 40% home; at least 3 days per week onsite in Waltham, MA; not eligible for fully remote work.