PHARMAFull-time
Pharmacovigilance Physician
REMOTE (IN)REMOTEPOSTED: 9/16/2026
PHARMAFull-time
HIRING ORGANIZATIONTHERMO FISHER SCIENTIFICLife Sciences / Scientific Instruments / Biotechnology
ROLE OVERVIEW
Pharmacovigilance Physician role providing medical oversight of drug safety activities across the pharmaceutical product lifecycle, including case review, safety signal assessment, aggregate reports, regulatory submissions and benefit-risk evaluation.
ROLE DEFINITION & RESPONSIBILITIES
- •Manage medical aspects of contracted pharmacovigilance activities across the product lifecycle
- •Ensure compliance with regulations, ICH guidelines, client directives and company SOPs
- •Provide medical consultation to project teams, associates and clients
- •Provide therapeutic and protocol training for assigned studies
- •Author or review safety sections of CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS and CTD modules
- •Conduct medical review of safety cases, serious adverse events and adverse events of special interest
- •Review coding listings and safety data for potential safety concerns
- •Evaluate safety data from solicited, spontaneous and literature sources
- •Identify and investigate safety signals
- •Contribute to label updates, literature review, dossier maintenance and risk-management activities
- •Support benefit-risk assessment and medical interpretation of safety data
Reporting Hierarchy: Reports within the Clinical Research/Pharmacovigilance organization; Provides consultation to project teams, associates and clients; May support sponsor meetings and business development activities; Exact reporting line and team size not specified
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- MD or equivalent or MBBS qualification
- 5+ years of pharmaceutical or biotech industry experience
- At least 2 years of pharmacovigilance/drug safety experience
- Working knowledge of pharmacovigilance regulatory requirements
- Ability to medically assess safety data from multiple sources
- Experience authoring complex documents and contributing to regulatory submissions
- Knowledge of adverse event reporting systems
PREFERRED QUALIFICATIONS
- •Clinical practice or academic medicine experience
- •Global pharmacovigilance experience
- •Experience in epidemiology, biostatistics, clinical development or medical affairs
- •Experience mentoring or training staff
- •Strong knowledge of FDA, ICH, EMA and GCP guidance
REQUIRED VERIFIED SKILLS
Pharmacovigilance
medical review
drug safety
ICSR
adverse events
serious adverse events
MedDRA
signal detection
PBRER
PSUR
DSUR
RMP
REMS
CTD
CSR
regulatory submissions
FDA
ICH
EMA
GCP
safety databases
benefit-risk assessment
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Employee health and wellbeing support, professional development, global collaboration and career development opportunities
The source posting does not disclose specific salary or bonus/equity figures. Compensation should be confirmed directly with Thermo Fisher Scientific during recruitment.
ORGANIZATION CONTEXT & CULTURE
Thermo Fisher Scientific is a global science and healthcare company whose PPD clinical research organization provides clinical research and drug development services worldwide.
TEAM SIZE: 125,000+ employees
INDUSTRY: Life Sciences / Scientific Instruments / Biotechnology
Culture: Science-focused and collaborative environment emphasizing innovation, quality, patient safety, professional development and global teamwork.
EXPECTED CAREER ROADMAP
Potential progression can include Senior Pharmacovigilance Physician, Safety Medical Lead, Medical Safety Lead and broader pharmacovigilance or clinical development leadership roles, depending on experience and organizational opportunities.
APPLICATION ADVISORY
Emphasize MD/MBBS qualification and 5+ years of pharmaceutical/biotech experience; clearly demonstrate 2+ years of pharmacovigilance medical review; highlight ICSR, SAE/AE review, MedDRA, signal detection and aggregate reporting; showcase experience with regulatory documents and FDA/ICH/EMA/GCP requirements; include examples of medical safety assessment and client communication.
RECOMMENDED TRAINING
1/5
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