Global Medical Safety Lead (Medical Director) – Remote, U.S.
Location: Remote (United States – Eastern or Central Time Zone Preferred)
Job ID: R-01334577
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote
About the Role
Thermo Fisher Scientific is seeking an experienced Global Medical Safety Lead (Medical Director) to support safety leadership for innovative therapies within a fast-growing global biotech organization. This position is fully remote within the United States and offers the opportunity to lead safety strategy across clinical development programs focused on autoimmune and specialty disease areas.
As a key member of the Global Medical Safety function, you will oversee the evaluation of medical safety data, guide benefit-risk assessments, and collaborate with global stakeholders to ensure the highest safety standards across assigned products.
Key Responsibilities
Lead strategic medical safety oversight for assigned products across multiple therapeutic areas.
Assess aggregate medical safety data, including signal detection, benefit-risk evaluation, and safety surveillance.
Oversee safety governance activities and contribute to global safety strategy.
Prepare and review safety sections for clinical and regulatory documents including study protocols, Investigator’s Brochures, Clinical Study Reports, and Informed Consent Forms.
Lead periodic safety reporting (PSUR, DSUR) and deliver high-quality safety documentation.
Ensure timely, accurate, and compliant preparation of medical safety responses to regulatory agencies.
Manage medical assessment of individual case safety reports (ICSRs) and confirm expedited reporting criteria.
Present safety data to internal teams, external partners, and Data Safety Monitoring Boards (DSMBs).
Support internal audits, inspections, and pharmacovigilance compliance activities.
Contribute to the creation and updates of SOPs, work instructions, templates, and cross-functional training materials.
Collaborate with global clinical development, regulatory affairs, medical affairs, and key opinion leaders.
Required Education and Experience
MD (Doctor of Medicine) or equivalent required.
Minimum 7 years of pharmaceutical/biotech industry experience, including at least 5 years in pharmacovigilance or drug safety (global exposure preferred).
Minimum 1 year of clinical practice or academic medicine experience.
Proven expertise in analyzing safety data across multiple sources.
Experience preparing regulatory submissions and complex safety documentation.
Working knowledge of global pharmacovigilance guidelines and reporting systems.
Background in epidemiology, biostatistics, clinical development, or medical affairs is advantageous.
Skills and Competencies
Strong scientific and analytical capabilities with attention to detail.
Ability to lead cross-functional teams and influence decision-making.
Excellent written and verbal communication skills with strong presentation expertise.
Ability to manage multiple priorities in a fast-paced environment.
Proficiency in Microsoft Office and safety-related digital systems.
Work Environment and Physical Requirements
Fully remote role with 10–20% travel, including possible international travel.
Frequent use of standard office equipment and computer systems.
Ability to remain stationary for extended periods (6–8 hours daily).
Occasional bending, twisting, and light lifting (up to 20 lbs).
Ability to communicate complex information clearly across diverse teams.
Ability to perform under pressure, manage multiple tasks, and maintain consistent attendance.
Benefits
Thermo Fisher Scientific offers a competitive compensation package, annual performance bonuses, comprehensive healthcare, and extensive career development opportunities. Employees join an organization recognized for innovation, scientific excellence, and a culture built on integrity, intensity, involvement, and innovation.
Gujarat :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Netherlands |Remote Australia :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Australia | North York | Mississauga | Richmond Hill | Uxbridge | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
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Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Rho |Jakarta :
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Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
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