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Physician, Post-Marketing Research
Thermo Fisher ScientificCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive medical oversight in pharmacovigilance, ensuring compliance with SOPs, regulatory requirements, and good clinical practices. Possesses strong clinical expertise, analytical skills, and the ability to mentor and train staff while effectively communicating complex information.
Highest-signal resume keywords
MD Or EquivalentClinical ExperiencePharmacovigilance ExpertiseKnowledge Of FDA, ICH, EMA, And GCP GuidelinesSafety Database Proficiency
About the role
Key responsibilities & impact- Provide medical oversight of pharmacovigilance activities to ensure SOPs, client directives, good clinical practice, and regulatory requirements are followed
- Attend and present at sponsor meetings
- Provide medical and pharmacovigilance consultation to clients and project team members
- Support business development activities as needed
- Manage 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, adverse events of special interest, and serious adverse events
- Review coding listings and/or full safety data to assess potential safety concerns
- Review adverse event and serious adverse event data from solicited, spontaneous, literature, and other sources
- Identify and investigate safety signals and contribute to management of assigned products’ benefit-risk profiles
Requirements
What you’ll need- MD or equivalent or MBBS (with 2 years of clinical experience) required
- Active medical licensure preferred
- Previous clinical experience for MD or equivalent in treating patients for 2 years is desirable in the specialty or sub-specialty associated with the applicant’s training
- Alternatively, experience in a Contract Research Organization, pharmaceutical company, as a principal investigator, or direct safety/pharmacovigilance experience providing the knowledge, skills, and abilities to perform the job
- Appropriate combinations of education, training, and/or directly related experience may be considered sufficient in some cases
- 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, problem-solving, oral and written communication, and presentation skills
- Ability to work independently and under pressure and prioritize sensitive, complex information
- Proficiency in basic computer applications
- Fluent in spoken and written English
- Excellent interpersonal, influencing, and team-building skills
- Good understanding of FDA, ICH, EMA, and GCP guidelines
- Working knowledge of relevant safety databases, MedDRA, biostatistics, data management, and clinical operations procedures
- Ability to mentor and train other staff
Benefits
Comp & perks- Health and wellbeing support
- Support and encouragement to create a healthy and balanced environment
- Global team environment
- Collaboration and development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical OversightSafety Data ReviewSignal DetectionAggregate Report ReviewAdverse Event AssessmentClinical Study Objectives UnderstandingDrug Development Process KnowledgeProtocol TrainingRisk ManagementBiostatistics
Soft Skills
Attention To DetailProblem-SolvingOral And Written CommunicationInterpersonal SkillsTeam-Building
Tools & Technologies
MedDRASafety DatabasesClinical Operations Procedures
Certifications & Qualifications
Active Medical Licensure
Industry Keywords
PharmacovigilanceGood Clinical PracticeClinical Research OrganizationAdverse EventsRegulatory Requirements