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

Thermo Fisher Scientific
Thermo Fisher Scientific
1-7 years
preferred by company
10 Dec. 24, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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./Canada)

Job ID: R-01334577
Employment Type: Full-Time
Category: Clinical Research / Pharmacovigilance
Work Mode: Fully Remote
Eligible Locations: United States & Canada (Preferred: Eastern or Central Time Zone)
Travel Requirement: 10–20% (Domestic and International, as required)


About the Organization

Thermo Fisher Scientific, through its PPD® Clinical Research Services portfolio, is a global leader in advancing life-changing therapies. Operating clinical trials in more than 100 countries, the organization delivers integrated laboratory, digital, and decentralized clinical trial solutions that support pharmaceutical, biotechnology, and healthcare innovation worldwide.

This opportunity is with a global, mid-sized biotechnology client focused on developing innovative treatments for autoimmune diseases. The organization is science-driven, fast-growing, and internationally recognized for its strong research foundation and patient-centric approach.


Position Overview

The Global Medical Safety Lead (Medical Director) will provide strategic and operational medical safety leadership for assigned products across global development programs. This role is critical in ensuring patient safety, regulatory compliance, and high-quality pharmacovigilance deliverables throughout the product lifecycle.

The position is fully remote and benefit-eligible. Candidates must be legally authorized to work in the United States without sponsorship.


Key Responsibilities

  • Lead medical safety assessment activities for assigned products across clinical development and post-marketing phases

  • Develop and execute safety signal detection, evaluation, and benefit–risk management strategies

  • Perform and oversee safety signal management, aggregate safety data reviews, and ad-hoc safety analyses

  • Lead cross-functional safety reviews involving Regulatory Affairs, Clinical Development, Medical Affairs, and external stakeholders

  • Contribute to the development and maintenance of global safety governance frameworks

  • Author, review, and provide strategic input into safety sections of global regulatory submissions (ISS, SCS, PSUR, DSUR, narratives)

  • Review and approve safety components of clinical and regulatory documents, including protocols, Investigator Brochures, CSRs, and Informed Consent Forms

  • Oversee medical review of Individual Case Safety Reports (ICSRs), including expedited reporting and SUSAR assessments

  • Lead preparation and presentation of safety data to Data Safety Monitoring Boards (DSMBs)

  • Provide medical safety expertise during regulatory inspections and internal audits

  • Support development and maintenance of Global Pharmacovigilance SOPs and controlled documents

  • Contribute to pharmacovigilance agreements and cross-functional safety training initiatives


Required Qualifications

  • MD or equivalent medical degree (mandatory)

  • Minimum 7 years of experience in the pharmaceutical or biotechnology industry

  • At least 5 years of hands-on experience in global pharmacovigilance or drug safety

  • Minimum 1 year of clinical practice or academic medicine experience

  • Strong working knowledge of global pharmacovigilance regulations and guidelines

  • Proven expertise in medical assessment of safety data from multiple sources

  • Experience authoring complex safety and regulatory documents

  • Familiarity with adverse event reporting systems and safety databases


Preferred Qualifications

  • Global safety experience across multiple regions

  • Background in epidemiology, biostatistics, clinical development, or medical affairs

  • Prior experience interacting with regulatory authorities and key opinion leaders


Core Skills and Competencies

  • Strong scientific judgment and analytical capabilities

  • Ability to manage multiple priorities in a fast-paced, matrixed environment

  • Demonstrated leadership, collaboration, and stakeholder influence skills

  • Excellent written and verbal communication skills

  • Proficiency in Microsoft Office and relevant clinical safety systems


Work Environment & Physical Requirements

  • Office-based remote work environment

  • Prolonged periods of computer-based work (6–8 hours per day)

  • Occasional domestic and international travel

  • Ability to work independently with sustained concentration and adaptability to changing priorities


Compensation & Benefits

Thermo Fisher Scientific offers a competitive compensation package, annual incentive bonus, comprehensive healthcare coverage, and a broad range of employee benefits. Employees benefit from a collaborative culture built on integrity, innovation, intensity, and professional growth.


Language Requirement

Proficiency in English is required to ensure effective communication and collaboration with global teams and business leaders, including stakeholders in the United States and other international locations.


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