The Position

Responsible for performing medical review and validation of incoming adverse events, ensuring the correct medical interpretation, including evaluation of expectedness and reportability. Ensures consistency in the evaluation of Adverse Event cases. Assures compliance and fulfilment of the requirements as to the evaluation, reporting and surveillance of clinical and post marketing safety information with US drug and device safety reporting regulations and ICH guidelines and internal procedures. The Associate Director Medical Review will contribute and maintain the safety profile of the company's product together with HQ.

Relationships

Reports to the Director, Patient Safety, Medical Review, with cross-functional working relationships within Clinical, Medical, Regulatory and Marketing. Interacts with counterparts in Global Safety. Provides medical and technical information to health care providers relating to Patient safety. Serves as an internal advisor regarding safety issues.

Essential Functions

• Liaises with Global Safety, as well as NNI medical, clinical and regulatory, on all relevant safety matters
• Narrative writing, medical evaluation of a case, reconciliation of databases, review of protocols, etc.
• Provide medical input in the safety review of ICSRs where the US affiliate has case processing responsibilities, namely post-marketing sources
• Responsible for performing review of individual safety reports for medical content, evaluation of expectedness/ listedness and assessing regulatory status for expedited reporting, and possible signal detection
• Performs aggregate medical review of post-marketing, non-serious adverse events in collaboration with Global Safety
• Handles local aggregate report activities, incl. review and safety input for assigned products, e.g. PBRERs, PADERs
• Provides guidance and expertise to case processing personnel in triaging and evaluating adverse events and malfunction report with respect to assessment of seriousness, expectedness/ listedness, and causality for FDA reportability. Serves as Patient Safety lead SME in PRB meetings for all assigned NN products
• Responsible for the determination of regulatory submissions for ICSRs and performs the quality check of the assessments in collaboration with the case processing teams
• Supports internal and external training activities such as Introduction program for new employees in Patient Safety, annual safety training for Patient Safety employees etc.
• Complies with all Federal regulations and company SOPs regarding complaint handling and regulatory reporting for adverse experiences, marketed product and clinical investigations
• Maintains up to date knowledge of the regulations and guidelines issued by FDA and ICH as well as other industry sources of information concerning current standards for safety surveillance and FDA reportability
• Performs gap analysis and impact assessment on new and revised regulatory reporting and safety surveillance regulations and guidelines issued by the FDA
• Provides Patient Safety input to assigned products Local Labeling Committee
• Reviews and disseminates information from the affiliate mailbox

Physical Requirements

0-10% overnight travel required.

Qualifications

• An M.D. /D.O. required, with up-to-date knowledge of clinical and therapeutic principals
• Minimum of one-year pharmaceutical industry experience required
• Computer literacy required
• Excellent communication Skills - written and verbal English are of significant importance to success in this position
• MedDRA coding experience required

The base compensation range for this position is $165,000 to $220,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.

Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.