Drug Safety Program Manager

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 last checked Jun 13, 2026

Salary

Not verified not verified - source not recorded; timestamp not recorded

401(k) match

Listed Source: EMPLR_CONTRIB_INCOME_AMT. source Last checked Jun 13, 2026.

Was this benefit information wrong? Tell us.

Schedule

Shift type

Not verified

Weekend work

Not verified

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 source-linked preview and links to the original posting.