Global Medical Safety Lead (Medical Director)
Location: Remote – North Carolina, USA
Job Type: Full-time
Work Schedule: Standard (Mon-Fri)
Work Setting: Fully remote, occasional domestic/international travel (10–20%)
Company: Thermo Fisher Scientific / PPD Clinical Research Portfolio
The Global Medical Safety Lead provides strategic medical safety leadership for assigned products in a cross-functional setting. This role ensures the safe use of products by assessing safety data, developing benefit-risk strategies, and collaborating with internal and external stakeholders.
Ideal candidates are based in the Eastern or Central Time Zone and are legally authorized to work in the U.S. without sponsorship.
Lead assessment of medical safety data for assigned products
Develop and execute safety signaling and benefit-risk management strategies
Provide strategic input and practical contributions to cross-functional teams
Oversee medical assessment of individual case safety reports (ICSR)
Lead preparation and review of safety sections in clinical/regulatory documents (e.g., study protocols, IBs, Clinical Study Reports, ICFs)
Support preparation of periodic safety reports (e.g., PSUR, DSUR) and ensure quality and consistency
Contribute to responses for regulatory authority inquiries
Work closely with internal stakeholders (Regulatory Affairs, Clinical Development, Medical Affairs)
Engage with external stakeholders (Key Opinion Leaders, regulatory agencies) to align safety communications
Participate in cross-functional initiatives, internal audits, and regulatory inspections
Contribute to development and updates of GPS SOPs and other controlled documents
Support adverse event reporting training and pharmacovigilance awareness activities
Assist in pharmacovigilance agreements with clinical or commercial partners
Lead review of aggregate safety data (regular or ad-hoc)
Participate in DSMB preparations and presentations
Ensure compliance with safety governance structures and organizational standards
MD degree or equivalent required
≥7 years relevant pharmaceutical/biotech industry experience
≥5 years in pharmacovigilance/drug safety (global experience preferred)
≥1 year clinical practice or academic medicine experience
Working knowledge of pharmacovigilance regulatory requirements and guidance documents
Experience in medical assessment of safety data from multiple sources
Experience authoring complex documents and contributing to regulatory submissions
Knowledge of adverse event reporting systems
Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus
Strong scientific and analytical skills
Ability to manage multiple tasks in a fast-paced environment
Leadership, motivation, and influence in multidisciplinary teams
Excellent presentation and communication skills
Proficiency in Microsoft Office and other relevant software
Primarily office-based, with exposure to electrical equipment
Occasional domestic/international travel
Stationary for 6–8 hours per day
Repetitive hand movements and frequent mobility
Occasional crouching, stooping, bending, twisting
Lifting/carrying objects up to 15–20 lbs
Ability to use a variety of computer software
Work independently with minimal guidance; handle variable tasks under stress
Regular and consistent attendance
Competitive salary and annual incentive plan
Healthcare and comprehensive employee benefits
Career development and growth opportunities
Culture emphasizing integrity, intensity, involvement, and innovation
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Queensland |Melbourne :
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Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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