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About the role
Key responsibilities & impact- Take ownership of pharmacovigilance and drug safety deliverables, applying your expertise to complex challenges
- Lead the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies
- Experience in SAE/AE processing for clinical trials
- Familiarity with EDC systems (e.g., RAVE) and Argus Safety
- Understanding of protocol timelines and regulatory reporting
- Support DSUR preparation
- Ability to mentor new joiners and review SOPs
- Familiarity with reconciliation processes
- Conduct thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation
- Prepare and submit comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations
- Collaborate with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities
- Oversee the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards
- Provide training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices
- Engage in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements
Requirements
What you’ll need- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards
- Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection
- Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations
- Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams
- Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite
- Ability to work independently and manage multiple priorities in a fast-paced environment
- Willingness to travel as required (approximately 15%)
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
PharmacovigilanceAdverse Event ProcessingData AnalysisSignal DetectionRegulatory ReportingProtocol UnderstandingSafety Data InterpretationDatabase ManagementSOP ReviewDSUR Preparation
Soft Skills
Analytical ThinkingCommunication SkillsInterpersonal SkillsCollaborationIndependent Work