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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 safety data analysis, adverse event reporting, and regulatory compliance. Proficient in collaborating with cross-functional teams and managing documentation for inspections and audits.
Highest-signal resume keywords
Pharmacovigilance ExperienceSafety Data AnalysisRegulatory Guidelines KnowledgeVeeva Vault ExperienceExcellent Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety Data AnalysisAdverse Event ReportingAggregate Report PreparationGxP Requirements KnowledgeMedical WritingRegulatory ReportingSignal DetectionBenefit-Risk EvaluationClinical Concepts UnderstandingDocument Management
Soft Skills
CollaborationIndependent WorkLogical CommunicationTeamworkPositive Work Environment
Tools & Technologies
Microsoft OfficeVeeva VaultElectronic Document Management Systems
Industry Keywords
PharmacovigilanceSafety MonitoringRegulatory AffairsR&D PrinciplesInspection ReadinessAudit ProcessesMedical Literature ReviewAdverse Event Case ReportingSignal Management ReportsBenefit-Risk Safety Reports
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Compile, review, validate, and analyze safety data from internal and external sources for robust benefit-risk assessments of non-High Profile Products
- Conduct systematic surveillance and critical review of scientific and medical literature for safety information
- Identify, evaluate, document, and communicate adverse event reports, emerging safety concerns, and published safety data
- Support signal detection, safety monitoring, aggregate report preparation, and ongoing benefit-risk evaluation
- Analyze, interpret, and synthesize published safety data
- Collaborate with cross-functional stakeholders on safety assessments, risk evaluations, and regulatory reporting
- Author and review aggregate reports and regulatory safety documents, including Annual Signal Management Reports and Benefit-Risk Safety Reports
- Manage and complete Veeva Vault RIM activities and workflows
- Partner with Regulatory Affairs, PV Affiliates, and other functional teams to gather data and ensure content consistency
- Maintain inspection- and audit-ready pharmacovigilance documentation, processes, and records; support inspections and audits
- Align activities with organizational objectives and foster a positive, collaborative work environment
Requirements
What you’ll need- Graduation in veterinary medicine, post-graduation in pharmacy, or another life science background
- A minimum of 1–3 years of industry experience in pharmacovigilance or medical writing
- Excellent oral and written communication skills, with ability to communicate logically and technically with global stakeholders
- High competency in Microsoft Office applications
- In-depth knowledge of GxP requirements and regulatory guidelines
- Sound understanding of operational Regulatory and R&D principles
- Strong understanding of medical terms, clinical concepts, and their relevance in adverse event case reporting from medical literature
- Understanding of aggregate report requirements and types of aggregate reports
- Ability to work independently or as part of a team and collaborate with global teams across geographies and time zones
- Experience with electronic document management systems, e.g., Veeva Vault
- Mastery of templates, styles, and submission-ready formatting
Benefits
Comp & perks- Diverse and inclusive work environment
- Opportunities to acquire new skills and experiences
- Travel up to 10% annually