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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Pharmacovigilance, including case processing, risk management, and regulatory compliance. Proficient in developing safety reports and managing quality systems while supporting clinical trials and audits.
Highest-signal resume keywords
Pharmacovigilance ExperienceRisk ManagementAggregate Safety ReportingRegulatory InspectionsClinical Trials Support
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Case ProcessingCausality AssessmentSafety MonitoringQuality Management System (QMS)Signal DetectionAdverse Event AssessmentPharmacovigilance SystemsLabel UpdatesTechnical Training DevelopmentCompliance Checks
Soft Skills
CommunicationCollaborationProblem-SolvingLeadership
Industry Keywords
PharmacovigilanceSafety Data Exchange Agreements (SDEAs)Risk Management Plans (RMPs)Global AuditsDigital TransformationHealth-Related FieldMultinational Environment
About the role
Key responsibilities & impact- Act as backup for the review and processing of individual safety reports (ICSRs) originating from the company’s territories, with a focus on compliance and quality checks
- Perform assessment of adverse events, including coding, causality assessment, severity, expectedness and product benefit–risk profile
- Support risk management activities, signal detection, safety monitoring and implementation of risk minimization measures
- Review and prepare pharmacovigilance regulatory documents, including Aggregate Safety Reports, Risk Management Plans (RMPs) and safety communications
- Provide support for company‑sponsored clinical trials and investigator‑initiated studies, ensuring compliance with safety requirements
- Participate in global audits and regulatory inspections, contributing to the maintenance of the area’s compliance status
- Implement and maintain the Pharmacovigilance Quality Management System (QMS), including monitoring of indicators, management of deviations and action plans
- Review and harmonize global pharmacovigilance procedures, policies and processes
- Support negotiations of Safety Data Exchange Agreements (SDEAs), due diligence processes, acquisitions, licensing and management of commercial partners
- Evaluate and monitor pharmacovigilance vendors and specialized consultancies
- Develop and deliver technical training for affiliates and interfacing areas
- Lead or participate in continuous improvement and transformation projects for the area’s global processes
- Propose label updates and other regulatory actions arising from the identification of new safety information
- Provide technical support for global regulatory requests and requirements related to product safety
Requirements
What you’ll need- University degree in Pharmacy or other health‑related field
- Advanced English and intermediate Spanish (Spanish is a plus)
- Solid experience in Pharmacovigilance, preferably in a multinational or global environment (Required)
- Experience in case processing and evaluation, risk management, aggregate safety reporting, audits and regulatory inspections (Required)
- Experience with clinical trials and safety monitoring is considered a plus (Desirable)
- Participation in digital transformation initiatives in drug safety is desirable (Desirable)
- Experience with pharmacovigilance systems
Benefits
Comp & perks- Medical insurance
- Dental insurance
- Meal allowance
- On‑site cafeteria
- Transportation allowance / company shuttle / parking – depending on the work location
- Company pharmacy/dispensary with free medications for you, your parents, spouse and children
- Life insurance
- Private pension plan to help you plan your future
- Childcare support where applicable (depending on work location)
- On‑site beauty salon
- On‑site gym
- Short Fridays to enjoy the day as you wish (6‑hour workday for employees not working shifts)
- Development programs offering partnered discounts with educational institutions
- Maternity leave
