Medical Director – M-SERM

Thermo Fisher Scientific

Medical Director leading pharmacovigilance safety evaluation and risk management for Thermo Fisher Scientific. Reviewing clinical safety data, regulatory reports, signals, labels, and risk-management documentation.

Posted 8/7/2026full-timeRemote • 🇨🇴 ColombiaLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Pharmacovigilance, including medical review, safety reporting, and compliance with regulatory guidelines. Proficient in mentoring staff and managing safety data while ensuring adherence to ICH, FDA, and EMA standards.

Highest-signal resume keywords

MD Or EquivalentClinical Experience In Medical ReviewWorking Knowledge Of FDA GuidelinesSafety Databases Such As ARGUSAbility To Mentor Pharmacovigilance Staff

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical ReviewSafety ReportingData ManagementBiostatisticsClinical Operations ProceduresDrug Development ProcessPharmacovigilance RegulationsSignal DetectionAdverse Event ReviewClinical Study Design

Soft Skills

Decision-MakingProblem-SolvingOrganizational SkillsAnalytical SkillsInterpersonal Skills

Tools & Technologies

ARGUSARISgMedDRA

Certifications & Qualifications

Active Medical License

Industry Keywords

PharmacovigilanceICH GuidelinesFDA GuidelinesEMA GuidelinesGCP GuidelinesRisk Management PlansClinical Trial Safety

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Maintain understanding of methods for recording project and administrative time, submitting expenses, and handling travel.
Ensure delegated Pharmacovigilance tasks are properly executed and comply with applicable regulations, ICH guidelines, client directives, project WPDs, and CRG policies and SOPs/WPDs.
Provide medical consultation to team members and answer project- and study-related medical questions.
Communicate with associates and clients to ensure procedures are followed appropriately.
Provide safety reporting training on assigned projects and studies as requested.
Medically review adverse-event and serious-adverse-event data from solicited, spontaneous, literature, and other sources.
Review adverse events of special interest, serious adverse events, and clinical outcomes events reported in clinical trials.
Perform contract-defined data review and validation, including coding listings and full safety data, to identify potential safety concerns.
Assist with writing and/or reviewing CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules, and related safety documentation.
Manage signal detection activities and scientifically review periodic safety reports.
Contribute to label updates, dossier maintenance, and risk management activities.
Mentor and train entry-level Pharmacovigilance staff and liaise with CRG groups and clients.

Requirements

What you’ll need

MD or equivalent required
At least one of the following: clinical experience with direct responsibility for diagnostic and treatment decisions comparable to 2 years, or direct experience in medical review and assessment of safety information/Pharmacovigilance comparable to 3 years
Fluent in spoken and written English
General medical knowledge of diagnostic and therapeutic approaches across multiple specialties
Working knowledge of FDA, ICH, EMA, and GCP guidelines
Understanding of basic biostatistics, data management, and clinical operations procedures
Working knowledge of the drug development process and guidelines for marketing authorization submissions and international clinical studies
Working knowledge of clinical program and study design, relevant endpoints, safety considerations, and the regulatory and commercial landscape
Working knowledge of marketed-product pharmacovigilance regulations
Working knowledge of Drug Safety Dictionaries such as MedDRA
Working knowledge of safety databases such as ARGUS and ARISg
Ability to mentor and train entry-level Pharmacovigilance staff
Flexibility to travel domestically and internationally
Proficiency in basic computer applications
Strong decision-making, problem-solving, organizational, analytical, communication, and interpersonal skills
History of an active medical license highly preferred

Benefits

Comp & perks

Fully remote work arrangement
Flexibility to travel domestically and internationally
Reasonable accommodation for individuals with disabilities during the application, interview, and employment process