Global Medical Safety Lead(Medical Director) - Remote U.S

1-7 years

Not Disclosed

Remote, USA

10 Nov. 26, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Global Medical Safety Lead (Medical Director) – Remote U.S.

Location: Remote, United States (Preferred: Eastern or Central Time Zone)
Job ID: R-01334577
Employment 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 medical safety strategy, benefit-risk assessment, and global pharmacovigilance initiatives for a leading biotechnology client. This fully remote position offers the opportunity to influence global safety governance, collaborate with cross-functional scientific teams, and contribute to the development of life-changing therapies for autoimmune diseases.

This role involves approximately 10–20% travel, including occasional international travel.

Must be legally authorized to work in the United States without sponsorship.

About the Organization

Thermo Fisher Scientific’s Clinical Research teams drive the PPD clinical research portfolio, supporting global pharmaceutical development across more than 100 countries. The Global Medical Safety Lead will join a scientifically driven, internationally expanding biotech company focused on advancing innovative treatments for autoimmune disorders.

Position Purpose

Lead medical safety activities for assigned products across the product lifecycle.
Assess, interpret, and communicate safety data from multiple sources.
Develop benefit–risk management strategies and safety signal detection activities.
Collaborate with clinical development, regulatory affairs, medical affairs, and external regulatory authorities to ensure alignment on safety communication and risk mitigation.

Key Responsibilities

Safety Strategy and Leadership

Provide strategic medical safety leadership for assigned global products.
Drive the execution of safety signaling, benefit–risk evaluations, and aggregate data reviews.
Lead cross-functional teams in the review and assessment of emerging safety data.
Contribute to the development of safety governance structures and processes.

Safety Operations and Documentation

Provide medical safety content for regulatory submissions, including ISS, SCS, narratives, and module contributions.
Author and review safety sections of protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and Informed Consent Forms (ICFs).
Oversee the medical evaluation of ICSRs and confirm expedited reporting criteria (e.g., SUSARs).
Lead preparation of periodic safety reports such as PSURs and DSURs.
Support responses to regulatory authority queries and ensure the accuracy and completeness of safety data.

Cross-Functional and Regulatory Engagement

Present safety data to Data Safety Monitoring Boards (DSMBs).
Participate in internal audits, health authority inspections, and safety-related governance committees.
Support pharmacovigilance agreements, SOP updates, and internal training on safety processes.
Engage with external experts, key opinion leaders, and regulatory agencies.

Required Education and Experience

MD degree or equivalent required.
Minimum 7 years of relevant experience in the pharmaceutical or biotech industry, with at least 5 years of experience in pharmacovigilance/drug safety (global PV experience preferred).
At least 1 year of clinical practice or academic medicine experience.
Demonstrated expertise in medical assessment of safety data, signal detection, and aggregate safety reporting.
Experience contributing to regulatory submissions and safety documentation.
Knowledge of global pharmacovigilance regulations, safety databases, and reporting systems.
Additional experience in epidemiology, biostatistics, clinical development, or medical affairs is an advantage.

Skills and Competencies

Strong analytical, clinical interpretation, and scientific judgment skills.
Ability to manage multiple complex tasks in a dynamic environment.
Proven ability to lead, collaborate, and influence cross-functional teams.
Excellent communication and presentation abilities.
Proficiency with Microsoft Office and medical safety systems.

Work Environment and Physical Requirements

Work performed in a remote office setting with use of standard office equipment.
Occasional domestic and international travel.
Ability to remain seated or standing for extended periods (6–8 hours).
Frequent hand movements and regular mobility required.
Occasional bending, lifting (15–20 lbs), and travel-related activities.
Ability to multi-task, concentrate intensely, and work independently with minimal supervision.
Consistent attendance is essential.

Benefits

Thermo Fisher Scientific offers competitive compensation, annual incentive bonuses, comprehensive health coverage, and a wide range of professional development opportunities. Employees benefit from a culture built on integrity, intensity, innovation, and involvement, with strong support for long-term career growth.

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Global Medical Safety Lead(Medical Director) - Remote U.S

Job Description

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