Global Safety Lead

13+ years

Not Disclosed

Lexington

10 Jan. 8, 2025

Job Description

Job Type: Full Time Education: MD/ PhD 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: Safety Surveillance Leader

Location: East Coast Global Development Hub, Novo Nordisk
Facilities: Lexington, MA, and Plainsboro, NJ

About the Department

Our East Coast Global Development Hub brings together top minds in life science innovation, with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research to late-stage clinical development, creating a distinct R&D community centered on collaboration, partnerships, and cutting-edge research across innovative modalities and therapeutic areas. This hub merges biotech speed and large pharmaceutical company quality, resources, and stability to develop new medicines for patients. We’re changing lives for a living. Ready to make a difference?

The Position

This leadership role is responsible for developing the safety strategy and major safety deliverables for the assigned programs within the East Coast Development Hub. This role involves ongoing assessment of safety profiles of products, collaborating with cross-functional teams, and communicating safety information to internal and external stakeholders. The ideal candidate is a motivated, collaborative, and science-driven global safety expert.

Key Responsibilities

Safety Profile Establishment

Develop and update the minimum mandatory safety text (MMST) for informed consent.
Own the safety sections of the Company Core Data Sheet (CCDS) for developmental products.
Maintain labelling for marketed products and contribute to the Product Labelling Committee (PLC).

Safety Surveillance

Perform ongoing surveillance of data for assigned products and take action when risks are identified.
Conduct literature surveillance for both marketed and development products.
Prepare Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).
Respond to inquiries from Health Authorities (HAs) and internal stakeholders.

Clinical Trial Safety

Provide safety input for Product Development Plans (PDP), Trial Protocols, and Investigator’s Brochure (IB).
Act as the safety representative in trial safety groups, especially in dose escalation decisions (Phase I trials).
Lead the coordination of safety-related activities across the Global Project Team (GPT) and other relevant teams.

Cross-functional Collaboration

Chair and participate in cross-functional safety committees and support activities related to Risk-Based Monitoring.
Ensure safety aspects are integrated into project plans and trial deliverables.
Provide safety training for investigators and participate in safety-related communications.

Physical Requirements

Approximately 10% overnight travel required.

Qualifications

Education

MD, PhD, or equivalent degree with 8+ years of relevant experience in global safety surveillance and/or clinical/drug development.
Alternatively, a life sciences/pharmacy nursing degree with 13+ years of experience.

Skills & Experience

Excellent verbal and written communication skills.
Strong organizational and problem-solving capabilities.
Ability to thrive in a fast-paced environment and maintain a positive attitude under pressure.

Equal Opportunity Employer

At Novo Nordisk, we recognize the importance of diversity and are committed to creating an inclusive culture that celebrates our employees, patients, and communities. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran status.

If you need special assistance or an accommodation to apply, please call 1-855-411-5290.

Apply Now: Novo Nordisk Careers

Together, we’re life-changing.

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Global Safety Lead

Job Description

Job Title: Safety Surveillance Leader

About the Department

The Position

Key Responsibilities

Safety Profile Establishment

Safety Surveillance

Clinical Trial Safety

Cross-functional Collaboration

Physical Requirements

Qualifications

Education

Skills & Experience

Equal Opportunity Employer

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