Pharmacovigilance Medical Writer Job at Medasource in Boston

Overview An established global biopharmaceutical company is seeking a Pharmacovigilance Medical Writer to support their Medical Safety / Pharmacovigilance team. The writer will focus on safety narrative development related to serious adverse events (SAEs), discontinued patients / studies, and adverse events of special interest (AESIs).

Responsibilities Author clinical safety narratives for SEEOMs (Special Events of Epidemiological or Operational Management), SAEOMs (Serious Adverse Event Overview Memos), and narratives for Adverse Events of Special Interest (AESIs).

Use existing templates and classification schemas to build timeline-based, data-rich stories that align with the full patient journey.

Review and synthesize multiple data sources to ensure consistency and accuracy across all narratives.

Perform quality control to confirm source data.

Craft narratives in a style aligned with regulatory expectations (e.g., FDA requirements).

Collaborate with internal teams (PV, medical writing, data management) to align on content, ensure data integrity, and meet timelines.

Requirements Bachelor’s degree in a life sciences or medically related field (MS, PharmD, or PhD preferred).

3–5+ years of medical writing experience in a clinical safety or pharmacovigilance context.

Strong background writing SAE and AESI narratives for late-phase clinical trials.

Demonstrated ability to work with complex clinical data and translate into clear, concise narratives.

Familiarity with regulatory submission standards.

Ability to work independently and meet fast-paced deadlines.

Experience with Psoriasis or Immunology trials is a plus, but not required.

Details Seniority level : Associate

Employment type : Full-time

Job function : Writing / Editing, Research, and Administrative

Industries : Biotechnology Research, Pharmaceutical Manufacturing, and Research Services

Location : Remote — must operate on Eastern Standard Time

Contract : 12 Months with potential for extension

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