Global Safety Lead

Novo Nordisk

8+ years

Not Disclosed

Plainsboro

10 Nov. 11, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Safety Lead – East Coast Development Hub

Location: Lexington, MA / Plainsboro, NJ
Department: Global Safety Surveillance

About the Department

Our East Coast Global Development Hub brings together top-tier talent in life science innovation, with facilities in Lexington, MA and Plainsboro, NJ. We support the entire program lifecycle, from early research to late-stage clinical development. We are building a dynamic, collaborative R&D community that bridges the speed and agility of biotech with the quality, resources, and stability of a global pharmaceutical leader. Together, we are advancing groundbreaking medicines that improve patients' lives. Are you ready to contribute to this mission and make a meaningful impact?

The Position

We are seeking a motivated, collaborative Global Safety Lead who will be accountable for developing and executing safety strategies and major safety deliverables for assigned programs within the U.S. East Coast Development Hub portfolio. In this leadership role, you will work closely with key internal and external stakeholders to assess and communicate the safety profile of molecules/products throughout their lifecycle.

Key Responsibilities

Product Safety Profile: Establish and maintain the safety profile for assigned products, ensuring that key safety data is communicated and incorporated into the overall development strategy.
Labelling & Informed Consent: Own the safety sections of the Company Core Data Sheet (CCDS) and ensure that the minimum mandatory safety text (MMST) is updated for use in Informed Consent Forms.
Safety Surveillance: Perform ongoing safety surveillance of Novo Nordisk products in both pre-approval and post-approval phases. This includes systematic review of data to identify safety signals or alerts and taking appropriate action to mitigate any identified risks.
Regulatory Reporting: Contribute to the preparation of regulatory documents such as Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and SUSAR reports.
Cross-functional Collaboration: Collaborate with clinical, regulatory, data management, and other internal teams, providing proactive safety input in product development and clinical trials.
Clinical Trial Safety: Serve as the safety representative in clinical trials, especially during early-phase trials (e.g., dose escalation decisions). Ensure that safety data is accurately reported and communicated to the trial team and external stakeholders.
Committee Leadership: Chair and participate in cross-functional safety committees throughout the lifecycle of products, ensuring safety input is integrated into key decision-making processes.
Training and Communication: Provide safety training to internal stakeholders and investigators, and respond to inquiries from Health Authorities (HAs), Ethics Committees (ECs), and other regulatory bodies regarding safety aspects of clinical protocols.
Data Monitoring Committees: Manage safety-related deliverables to/from Data Monitoring Committees (DMCs) and other external safety committees.
Risk-Based Monitoring: Provide safety input to risk-based monitoring activities and ensure alignment across various project deliverables.

Physical Requirements

Approximately 10% overnight travel required.
Ability to lift 0-10 lbs.

Qualifications

MD, PhD, or equivalent degree with 8+ years of relevant experience in global safety surveillance and/or clinical/drug development OR a life sciences/pharmacy/nursing degree with 13+ years of relevant experience.
Strong understanding of safety surveillance processes and regulatory requirements.
Proven ability to collaborate across multiple functional teams and manage complex safety data.
Excellent verbal and written communication skills to effectively present complex safety data and strategies to both internal and external stakeholders.
Strong organizational and problem-solving capabilities, with the ability to thrive in a fast-paced and dynamic environment.
Ability to work under pressure and maintain a positive, solution-focused attitude.

Working at Novo Nordisk

At Novo Nordisk, we believe in a collaborative approach to improving patient outcomes. With a legacy of over 100 years of innovation in chronic disease care, our team of over 63,000 employees is united by a common purpose: to help millions of patients around the world live better lives. We are committed to providing an inclusive work environment where diverse perspectives thrive and creativity flourishes.

Equal Opportunity Employer

Novo Nordisk is an equal opportunity employer, and we strive to create a diverse and inclusive workplace. We welcome applications from all individuals, regardless of race, ethnicity, gender identity, sexual orientation, disability status, or any other protected characteristic.

How to Apply

To apply for this exciting opportunity, please submit your CV and cover letter via the Apply button on the Novo Nordisk website.

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