Associate Medical Director, Global Safety Medical Review

Overview

Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality and is now advancing a robust pipeline of investigational RNAi therapeutic medicines. Please visit www.alnylam.com for more information.

The Associate Medical Safety Director role is responsible for performing medical case review and providing medical expertise across individual case safety assessment, with emphasis on maintaining a consistent and harmonized medical review approach. This role will support ongoing review of safety data and aggregate datasets to identify emerging trends, patterns, inconsistencies, and potential safety signals, and will provide medical and clinical input into data review plans, safety surveillance activities, and safety monitoring strategies. The Associate Medical Safety Director will interface across all levels and functional areas of SRM and partner closely with Clinical Development, Data Management, Pharmacovigilance, and other cross-functional teams. The role will also support medical device safety assessment, including review and evaluation of device-related safety information and potential safety concerns.

Summary of Key Responsibilities

• Perform daily medical review and causality assessment of ICSRs in an accurate, consistent, and timely manner to contribute to the continuous signal detection and management process.
• Support and participate in medical device safety assessments, including evaluation of MDR-related cases and determination of whether reported events meet applicable criteria for public health threats, regulatory reporting, escalation, or further medical assessment.
• Collaborate with other pharmacovigilance colleagues to align a harmonized approach to identifying, evaluating, and communicating safety issues.
• Identify topics for escalation and collaborate with Safety Product Leads to investigate potential safety signals.
• Support and participate in the ongoing review of safety data and aggregate datasets to identify emerging trends, patterns, inconsistencies, and potential safety signals.
• Provide medical and clinical input into data review plans, surveillance activities, and safety monitoring strategies, ensuring appropriate and consistent medical assessment of safety information.
• Collaborate with SRM Quality and Case Management teams to identify case review issues and inconsistencies and work on addressing these issues under the leadership of the Head of Medical Review.
• Participate in process improvements for the Medical Review team.
• Maintain close communication with the case processing and medical case review vendors.

Qualifications 

• MD degree with a minimum of 1 year of clinical medical practice required.
• Minimum of 3 years of pharmaceutical industry experience in a medical review or related pharmacovigilance role required.
• Strong clinical acumen with broad knowledge and experience across multiple therapeutic areas.
• Demonstrated ability to synthesize, critically evaluate, and interpret safety data from multiple sources, including individual case safety reports, aggregate safety data, and other relevant safety information.
• Strong analytical, critical-thinking, and problem-solving skills, with the ability to assess complex medical and safety issues and identify areas requiring further investigation or escalation.
• Excellent written and verbal communication skills, with the ability to effectively communicate medical and safety findings to cross-functional stakeholders.
• Strong understanding of international pharmacovigilance regulations and drug safety requirements. Working knowledge of applicable FDA, EU, and ICH guidelines, regulations, and initiatives governing safety reporting and processing, particularly within the clinical trial environment, is highly preferred.
• Knowledge of or experience in medical review of medical devices and/or combination-product safety information is preferred.
• Ability to work effectively in a fast-paced, complex, and collaborative environment while managing multiple priorities and meeting rapidly approaching timelines.
• Demonstrated ability to work collaboratively with cross-functional teams, case processing teams, medical review vendors, and other pharmacovigilance stakeholders to ensure high-quality, consistent, and timely safety assessments.

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