Position Overview

The Medical Reviewer is responsible for conducting medical case reviews and providing expertise in all aspects of the review process, with a strong focus on ensuring a harmonized approach. This role collaborates across all levels and functional areas of Global Patient Safety & Risk Management (GPSRM) while partnering closely with Clinical Development and Data Management teams.

The ideal candidate will demonstrate excellent medical judgment, strong analytical skills, a deep understanding of the drug safety lifecycle, and a flexible, hands-on approach with a strong sense of urgency.

Key Responsibilities

• Medical Case Review & Causality Assessment

  • Perform daily medical review and causality assessment of Individual Case Safety Reports (ICSRs) with accuracy, consistency, and timeliness.
  • Contribute to continuous signal detection and management processes.

• Safety Issue Identification & Escalation

  • Collaborate with pharmacovigilance colleagues to establish a harmonized approach for identifying, evaluating, and communicating safety issues.
  • Identify topics for escalation and work with safety product leads to investigate potential safety signals.

• Quality & Compliance

  • Partner with GPSRM Quality and Case Management teams to identify and address case review inconsistencies under the guidance of the Head of Medical Review.
  • Maintain close communication with case processing and medical case review vendors to ensure adherence to compliance standards.

• Process Improvement & Cross-Functional Collaboration

  • Contribute to ongoing process enhancements for the Medical Review team.
  • Engage with cross-functional teams to optimize the medical review workflow.

Qualifications

Alnylam fosters an entrepreneurial, fast-paced environment that values hard work, creativity, flexibility, and a problem-solving mindset. With a strong pipeline and significant resources, this role presents an opportunity to make a meaningful impact on the company’s growth.

The ideal candidate will possess the following personal and professional characteristics:

• Education & Experience

  • Medical Degree (MD) with a minimum of 1 year of medical practice (required).
  • Minimum of 2 years of pharmaceutical industry experience in pharmacovigilance or clinical research.
  • Experience in medical case review is a strong plus.

• Technical & Regulatory Expertise

  • Strong clinical acumen with broad therapeutic area knowledge.
  • Ability to synthesize and analyze safety data from multiple sources.
  • Proficiency in problem-solving within a complex, dynamic environment.
  • Expertise in international drug safety regulations, including FDA, EU, and ICH guidelines.
  • Working knowledge of safety reporting and processing in clinical trial settings (highly preferred).
  • Experience managing compliance or audits is a plus.

• Soft Skills & Work Ethic

  • Strong written and verbal communication skills, preferably with experience in medical/scientific writing.
  • Ability to work under tight deadlines in a fast-paced environment.
  • High level of collaboration, adaptability, and attention to detail.