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Drug Safety Program Manager

Alkermes - Waltham, MA, United States

Posted Apr 9, 2026

Benefits

Parental leave
Not verified
Non-birth-parent leave
Not verified
Family-building benefits
  • Fertility benefits: Not verified
  • Adoption assistance: Not verified
  • Surrogacy assistance: Not verified
Mental health support
Not verified
Relocation assistance
Not verified
Childcare support
Not verified
Learning budget
Not verified
Verification
Not verified checked Jun 13, 2026
Salary
$145K-$158K From the posting source checked Jun 20, 2026
401(k) match
Reported from DOL Form 5500 industry filing (not employer-specific)

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Market context

U.S. role benchmark (BLS OEWS)
$61,842 U.S. median for this role
Projected growth (BLS Employment Projections)
+1.9% - Slower

145% above the BLS role benchmark for operations aggregate.

Matched to SOC 11-1021 - Operations aggregate by role bucket.

Source: U.S. Bureau of Labor Statistics, OEWS, May 2024 and Employment Projections, 2024-2034.

Role

Role function
Operations From the posting source checked Jun 20, 2026
Seniority
Mid From the posting source checked Jun 20, 2026

Schedule

Shift type
Not verified
Weekend work
Not verified

Company

Equity
Offered Verified - SEC 10-K source checked Jun 20, 2026

Application

Cover letter
Not verified
Assessment
Not verified
Deadline
Not stated

Where they hire

State eligibility is not yet verified.

About this role

Drug Safety Program Manager Waltham, MA, United States 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

Read the full description at hbap.fa.us1.oraclecloud.com. FewerJobs shows a preview and links to the original posting.

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Apply link verified; last checked Aug 3, 2026.

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