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Pharmacovigilance Physician
Thermo Fisher Scientific. Provide medical oversight of pharmacovigilance activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in pharmacovigilance and drug safety, with a strong focus on regulatory compliance, medical assessments, and safety data analysis. Proficient in authoring complex regulatory documents and providing medical oversight throughout the pharmaceutical product life cycle.
Highest-signal resume keywords
MD Or Equivalent5+ Years Experience In Pharmaceutical/Biotech Industry2+ Years Experience In Pharmacovigilance Medical ReviewWorking Knowledge Of FDA, ICH, EMA And GCP GuidelinesExcellent Oral And Written Communication Skills
ATS Keywords
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Hard Skills
PharmacovigilanceMedical ReviewSafety Data AnalysisRegulatory SubmissionsAdverse Event ReportingSignal DetectionClinical Operations ProceduresBiostatisticsData ManagementMedical Assessments
Soft Skills
Attention To DetailOrganizational SkillsProblem-Solving SkillsAbility To Work IndependentlyMentoring And Training
Tools & Technologies
Safety DatabasesMedDRABasic Computer Applications
Industry Keywords
Good Clinical PracticeRegulatory RequirementsPharmaceutical Product Life CycleClinical Study ObjectivesPatient Safety
About the role
Key responsibilities & impact- Provide medical oversight of pharmacovigilance activities
- Ensure compliance with company SOPs, client directives, good clinical practice, and regulatory requirements
- Attend and present at sponsor meetings
- Provide medical and pharmacovigilance consultation to clients and project team members
- Support business development activities as needed
- Manage all medical aspects of contracted pharmacovigilance tasks across the pharmaceutical product life cycle
- Provide therapeutic and protocol training on assigned studies
- Write and/or review safety sections of CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules
- Scientifically review aggregate reports, contribute to label updates, review literature, and support dossier maintenance and risk management activities
- Medically review cases and adverse events of special interest and serious adverse events
- Perform data reviews, including coding listings and full safety data, to assess potential safety concerns
- Review adverse event and serious adverse event data from solicited, spontaneous, and literature sources
- Identify and investigate safety signals
- Contribute to management of assigned products’ benefit-risk profiles
Requirements
What you’ll need- MD or equivalent or MBBS qualified graduate
- 5+ years of experience in the pharmaceutical/biotech industry
- At least 2 years of experience in pharmacovigilance/drug safety
- At least 2+ years of experience in pharmacovigilance medical review activities
- Working knowledge of pharmacovigilance regulatory requirements and guidance documents
- Ability to perform medical assessments of safety data from multiple sources
- Experience authoring complex documents and contributing to regulatory submissions
- Knowledge of adverse event reporting systems
- Working knowledge of FDA, ICH, EMA and GCP guidelines
- Working knowledge of safety databases, MedDRA, biostatistics, data management, and clinical operations procedures
- Proficiency in basic computer applications
- Fluent in spoken and written English
- Clinical expertise with attention to detail, quality and patient safety
- Excellent medical knowledge of physiology and pharmacology
- Understanding of clinical study objectives and the complete drug development process
- Technical, analytical, organizational and problem-solving skills
- Excellent oral, written communication and presentation skills
- Ability to work independently and under pressure
- Ability to analyze and prioritize sensitive complex information
- Ability to act as a mentor/trainer to other staff
Benefits
Comp & perks- Global team environment
- Career development opportunities
- Resources to achieve individual career goals
- Collaboration and professional development
- Healthy and balanced work environment
- Occasional domestic and international travel opportunities