Global Safety Lead

About the Department                                                                                                                                             

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

This leadership role is accountable for developing the safety strategy, major safety deliverables for assigned programs within the U.S. East Coast Development Hub portfolio in close collaboration with key stakeholders from Global Safety Surveillance and other cross functional teams.

 

Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned molecules/products and communicate safety information to internal and external stakeholders.

 

Relationships

This position will report to Senior Global Safety Lead/Director/Senior Director – Safety Surveillance, U.S. East Coast Development Hub.

 

Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality, and other affiliates.

 

External stakeholders include Healthcare professionals, HAs, ECs, DMCs, and Academia.

 

Individual Contributor Role with no direct reports.

 

Essential Functions

• Establishment of the product safety profile:
  • Develop and update the minimum mandatory safety text (MMST) for use in the Informed Consent
  • Own the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products
  • Maintain the labelling for marketed products and is member of the Product Labelling Committee (PLC) Review Group
• Safety surveillance of Novo Nordisk products during pre-approval and post-approval phases:
  • Perform ongoing and systematic surveillance of all accessible data within allocated product area(s), takes initial actions to mitigate risks in case a safety signal or alert is detected or aggravated and documents the results of the safety surveillance for the period
  • Conduct periodic literature surveillance for marketed products and for development products (if applicable)
  • Provide input to preparation of Development Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as required by Has
  • Respond to requests from HAs and internally from NN affiliates and HQ functions
  • Conduct product training within therapeutic area of responsibility

• Chairmanship/membership of the NN cross-functional safety committees:
  • Participate as a member of the first safety committee chaired by non-clinical, where Safety Surveillance will resume chairmanship going forward
  • Establish, operate and chairs the safety committee throughout lifecycle of the actual product
• Responsible for all areas related to patient safety in clinical trials
  • Act as member of the trial safety group for dose escalation decisions (phase I trials)
  • Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator’s Brochure (IB), integrated safety summaries, abstracts and planned publications
  • Provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conducts Investigator training as required
  • Provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs)
  • Establish and ensure deliverables to/from Data Monitoring Committees (DMCs)

• Is safety representative in Trial Squad:
  • Plan, execute and drive all activities related to safety and ensure coordination with other project deliverables
• Is safety representative in cross functional project teams as needed e.g. Global Project Team (GPT)
  • Plan, execute and drive all activities related to s