Program Safety Lead, GPS Medical Science- Job ID 1692b

Role Summary

Program Safety Lead to champion safety excellence, drive compliance, and shape strategy across our growing portfolio in a global pharmacovigilance organization.

Responsibilities

• Define safety strategy for assigned development and marketed products in collaboration with cross-functional teams
• Serve as the safety lead for assigned products, providing strategic recommendations and oversight of patient safety activities
• Ensure compliance with global pharmacovigilance regulations, including signal detection, evaluation, and risk management
• Develop and maintain safety surveillance and risk management plans for drug development programs
• Oversee identification and evaluation of safety signals and ensure timely escalation and resolution
• Provide medical and safety input for expedited and aggregate safety reports (e.g., SUSARs, PSURs, DSURs, IND Annual Reports)
• Contribute to safety sections of labeling, investigator brochures, protocols, informed consent forms, and regulatory submissions
• Collaborate with internal and external stakeholders on pharmacovigilance agreements, audits, and regulatory inspections
• Monitor industry best practices and evolving global safety regulations; recommend updates to policies and SOPs
• Act as a patient safety advisor across Clinical Development, Medical Affairs, Commercial, and PV teams

Qualifications

• Required: Doctoral degree — preferably an MD (or equivalent), PhD, PharmD — professional English proficiency
• Ten years of industry pharmacovigilance experience in a fast-paced biopharmaceutical company
• Leadership experience within the safety profile of products assigned within a matrix organization
• Endocrinology Therapeutic Area experience
• Demonstrated skills in clinical medicine; at least 1 year of clinical practice experience preferred

Skills

• Strategic thinking with hands-on execution and mentoring
• Ability to navigate uncertainty and adapt quickly to changing priorities
• Proven track record delivering results in dynamic, fast-paced settings

Education

• Doctoral degree (MD or equivalent, or PhD, PharmD) required

Additional Requirements

• Travel up to 20% domestically and internationally
• Hybrid office location: Princeton, NJ or Palo Alto, CA