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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in drug safety and pharmacovigilance, including medical review of ICSRs and compliance with global regulations. Proficient in safety data analysis, risk management, and collaboration with regulatory agencies.
Highest-signal resume keywords
Medical Degree (MBBS or Higher)Drug Safety and Pharmacovigilance ExperienceICSR Medical Review ProficiencyKnowledge of US and EU Drug Safety RegulationsSafety Data Collection and Interpretation
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 Review of ICSRsCausality AssessmentSafety SurveillanceBenefit-Risk AssessmentDrug Safety MonitoringCoding and Use of SMQsAnalysis of Similar Event GenerationPeriodic Benefit-Risk Evaluation ReportsAggregate Safety ReportsRegulatory Compliance
Soft Skills
Excellent Verbal CommunicationExcellent Written CommunicationPresentation SkillsCollaborationRelationship Building
Industry Keywords
PharmacovigilanceCIOMSFDAPMDAEMAICH GuidelinesClinical TrialsDrug Safety RegulationsSafety TrainingSOP Development
About the role
Key responsibilities & impact- Analyze, review, and interpret non-clinical and clinical safety data
- Perform medical review of ICSRs and other drug safety information from clinical trials, spontaneous and solicited reports, aggregate reports, and literature reports
- Provide technical and medical expertise in ICSR causality assessment and assess quality within the ICSR process
- Identify process improvement opportunities and drive changes
- Contribute to aggregate safety reports, including development safety update reports and periodic benefit-risk evaluation reports
- Provide medical input on new and existing safety documents to ensure regulatory compliance
- Contribute to Standard Operating Procedures, Working Instructions, and guidance documents
- Contribute to safety and pharmacovigilance training programs
- Provide safety training at investigator meetings
- Collaborate with Regulatory Affairs on reporting pharmacovigilance and drug safety information to regulatory agencies and prescriber communities
- Serve as a subject matter expert for drug safety and pharmacovigilance service vendors
- Train and mentor Pharmacovigilance Physicians and Specialists
- Ensure compliance with global PV regulations and guidelines, including CIOMS, FDA, PMDA, EMA, and ICH
- Maintain medical knowledge and current knowledge of drug safety, pharmacovigilance regulations, safety surveillance, and risk-management practices
- Collaborate with Sitero safety teams, CROs, and partners on benefit-risk assessment and safety communication
Requirements
What you’ll need- 1-3 years’ experience in Clinical Practice required
- 1+ year of experience in Drug Safety and Pharmacovigilance in a pharmaceutical or biotech company, CRO, or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products preferred
- Medical Degree (MBBS or higher) from a recognized medical school
- Good working knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines
- Demonstrated experience with medical drug safety assessments, drug safety surveillance, and monitoring activities
- Proficiency with medical review of ICSRs, including coding and use of SMQs, expectedness assessments, causality assessments, narrative review, generation of Analysis of Similar Event and company comment statements, and benefit-risk assessment
- Experience with safety data collection and interpretation from clinical trials, literature, solicited reports, and post-marketing environments
- Ability to build relationships, collaborate, and influence across disciplines and with outside stakeholders
- Excellent verbal, written, and presentation skills
- Innovative, collaborative, initiative-taker
- Willingness to work in shifts as needed
Benefits
Comp & perks- Competitive salary
- Variable pay
- Paid time off
- Healthcare benefits
- Retirement benefits