Position
Associate Director - Medical Review
Location: Plainsboro, NJ or remote
Job Category: Regulatory Affairs & Safety - Pharmacovigilance
About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. CMR is involved in everything from healthcare-provider interactions and regulatory strategies with the FDA to medical education and new product development. We are driven by a patient-centered focus and aim to continuously find innovative ways to improve quality of life for patients. Are you ready to be part of this journey?
The Position
As the Associate Director, Medical Review, you will perform medical reviews and validate incoming adverse events. Your role will be crucial in ensuring the correct medical interpretation of these cases, including evaluation of expectedness and reportability. Additionally, you will ensure compliance with U.S. drug and device safety reporting regulations, ICH guidelines, and internal procedures.
Key Responsibilities
Collaborate with Global Safety and NNI Medical, Clinical, and Regulatory teams on safety-related matters.
Write narratives and perform medical evaluations of safety cases, including reconciling databases and reviewing protocols.
Provide medical input for safety reviews of Individual Case Safety Reports (ICSRs), focusing on post-marketing sources.
Evaluate adverse event reports for medical content, expectedness/listedness, and regulatory status for expedited reporting and signal detection.
Perform aggregate medical reviews of non-serious adverse events and contribute to PSURs, PBRERs, and PADERs.
Guide and mentor case processing personnel in evaluating adverse events and malfunction reports.
Ensure compliance with all FDA and ICH guidelines regarding complaint handling and regulatory reporting.
Participate in training programs and ensure up-to-date knowledge of safety surveillance and reporting regulations.
Physical Requirements
0-10% overnight travel required.
Qualifications
M.D. / D.O. required, with knowledge of clinical and therapeutic principles.
Minimum of one year of pharmacovigilance experience.
MedDRA coding experience is required.
Strong communication skills (written and verbal) in English.
Computer literacy is necessary.
Base compensation range: $170,000 to $204,000. In addition, this role is eligible for a company bonus based on individual and company performance.
Novo Nordisk also offers long-term incentives, employee benefits (medical, dental, vision, life insurance, 401(k), and more), flexible vacation policies, and parental leave.
How to Apply
The job posting is anticipated to close on February 25, 2025, though the deadline may be extended. To apply, visit Novo Nordisk Careers.
Diversity & Inclusion
At Novo Nordisk, we are committed to creating an inclusive work environment that celebrates diversity in all its forms. We aim to provide equal opportunities to all applicants and encourage people from diverse backgrounds to apply.
Related Opportunities
Senior Director - Safety Surveillance (Plainsboro, US)
Associate Director - Global Safety (Plainsboro, US)
Associate Director - Regulatory Affairs - Advertising & Promotion (Plainsboro, US)
About Novo Nordisk
Novo Nordisk A/S
Novo Alle 1, 2880 Bagsværd, Denmark
Phone: +45-4444-8888
CVR-no. 24256790
We strive to improve the lives of people living with chronic diseases like diabetes and rare blood and endocrine disorders. For more information, visit our product page.
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