Associate Medical Director, Global Safety Medical Review

Alnylam Pharmaceuticals

23h

About The Position

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 Medical Reviewer role is to perform medical case review and to provide expertise on all aspects of it with emphasis on harmonization of medical review approach. This role will interface across all levels and functional areas of GPSRM and partner with the clinical development as well as Data Management teams. The exceptional candidate that we seek will have an excellent medical judgment, strong analytical skills, understanding of lifecycle of drug safety and a flexible, hands-on nature with a high sense of urgency.
Alnylam prides itself on its entrepreneurial, fast-paced environment where success is rapidly rewarded. There is a strong pipeline, significant resources, and every intention of continuing the phenomenal rate of success and growth. This position offers an opportunity to have tremendous impact on the growth of the company. The culture values hard-work, creativity, flexibility, collaboration and a hands-on, problem-solving attitude.

Requirements

• Medical Degree with a minimum of 1 year of medical practice is required
• Must have a minimum of 2 years of pharmaceutical industry experience within pharmacovigilance or clinical research
• Sound clinical acumen and a wide range of therapeutic area knowledge.
• Ability to synthesize and analyze safety data from various sources. Proficiency in problem-solving within a highly complex environment
• Strong communications skills, both written and spoken, ideally with experience in medical / scientific writing
• Expertise in international regulations governing drug safety. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments highly preferred
• Ability to work in fast-paced environment with rapidly approaching timelines is important

Nice To Haves

• Experience in medical case review is a strong plus
• Experience in managing compliance or audits is a plus

Responsibilities

• Perform daily medical review and causality assessment of ICSRs in accurate, consistent, and timely manner to contribute to continuous signal detection and management process
• Collaborate with other pharmacovigilance colleagues to align on 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
• Collaborate with GPSRM Quality and Case Management teams to identify case review issues and inconsistency and work on addressing these issues under the leadership of 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

Benefits

• comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 1,001-5,000 employees