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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance processes, regulatory compliance, and safety data management, with a strong ability to collaborate across multidisciplinary teams. Proficient in managing individual case safety reports and ensuring adherence to global pharmacovigilance standards.
Highest-signal resume keywords
Pharmacovigilance ExperienceRegulatory Compliance KnowledgeIndividual Case Safety Report ManagementAudit and Inspection ReadinessCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
PharmacovigilanceDrug SafetyGVP Guidance DocumentsGxP Quality ComplianceSafety Data CollectionPharmacovigilance Document PreparationCase Management in Global Safety DatabaseVendor ManagementAdverse Event ReportingContinuous Improvement Initiatives
Soft Skills
Planning SkillsOrganizational SkillsOral CommunicationWritten CommunicationProblem-Solving Skills
Tools & Technologies
Microsoft Office SuiteRegulatory Authority DatabasesGlobal Safety Database
Industry Keywords
Pharmaceutical IndustryBiotech IndustryRegulatory AuthoritiesPharmacovigilance OperationsSafety Business Processes
About the role
Key responsibilities & impact- Support oversight, harmonization and maintenance of regional pharmacovigilance activities, processes and deliverables
- Contribute to pharmacovigilance systems for assigned countries or regions and align them with global GPS processes and standards
- Monitor and communicate applicable pharmacovigilance legislation, regulatory expectations and safety requirements
- Promote awareness of pharmacovigilance obligations and support compliance with local, regional and global requirements
- Manage and maintain company and user profiles in regulatory authority databases and portals
- Collaborate with Regulatory, Medical, Quality, Legal, Commercial and other teams
- Develop relationships with cross-functional teams involved in adverse event reporting and safety data collection
- Support oversight of individual case safety report processes and timely processing into the Global Safety Database
- Support oversight and operational management of pharmacovigilance outsourcing vendors
- Participate in GPS audit and inspection readiness, inspection support and management
- Maintain knowledge of the company product portfolio, disease areas and marketed and developmental products
- Contribute to continuous improvement and innovation initiatives for regional pharmacovigilance efficiency and process maturity
- Perform other appropriate and requested tasks
Requirements
What you’ll need- Bachelor’s or Master’s degree in pharmacy, nursing, healthcare, life sciences or another relevant scientific field
- Approximately 5 to 7 years of experience in the pharmaceutical or biotech industry, regulatory authorities or related environment
- Solid experience in pharmacovigilance or drug safety
- Working knowledge of pharmacovigilance regulatory requirements, GVP guidance documents and applicable GxP quality and compliance expectations
- Experience preparing, reviewing or maintaining pharmacovigilance documents, procedures, work instructions or related controlled documents
- High experience with individual case safety report processes and management of cases into a Global Safety Database
- Experience overseeing or managing pharmacovigilance outsourcing vendors, including operational performance, quality follow-up and issue management
- Experience in audit and inspection readiness, inspection support or participation in pharmacovigilance inspections preferred
- Knowledge of regional pharmacovigilance operations, safety data collection and cross-functional PV processes preferred
- Good planning and organizational skills
- Good oral and written communication skills, including communicating complex issues to different audiences
- Ability to collaborate effectively across multidisciplinary and global teams
- Understanding of safety business processes, adverse event collection and pharmacovigilance systems
- Problem-solving skills
- Relevant computer skills, including proficiency with Microsoft Office Suite
- Fluency in written and spoken English; other languages are an asset
- Candidates must be based in Belgium or Switzerland
Benefits
Comp & perks- Short-term and long-term incentives program eligibility
- Locally applicable annual base salary hiring range shared during the recruitment process
- Inclusive environment and equal consideration for employment without discrimination
- Opportunities for growth