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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance and regulatory compliance, with a strong focus on safety processes, risk management, and cross-functional collaboration. Proficient in developing and enhancing pharmacovigilance systems while maintaining knowledge of evolving regulations and industry standards.
Highest-signal resume keywords
Pharmacovigilance ExpertiseRegulatory ComplianceDrug Safety KnowledgeCross-Functional CollaborationPresentation 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
PharmacovigilanceRegulatory RequirementsGVP GuidanceDrug Development ProcessGXP Quality ComplianceAdverse Event ReportingKPI ContributionDocument AuthoringProcess ImprovementData Collection Systems
Soft Skills
Communication SkillsOrganizational SkillsProblem SolvingConflict ResolutionTeam Collaboration
Tools & Technologies
Microsoft Office Suite
Certifications & Qualifications
Master’s Degree in PharmacyPharmDMD
Industry Keywords
Pharmaceutical IndustryBiotech IndustrySafety RegulationsFDA InteractionsPharmacovigilance AgreementsGPS ProcessesInspection ReadinessContinuous ImprovementAdverse Event ReportingProduct Portfolio Knowledge
About the role
Key responsibilities & impact- Serve as scientific expert and pharmacovigilance resource to external and internal partners within the country/region
- Assess current processes for adherence to local/regional safety regulatory requirements and develop or enhance processes as needed
- Act as the main pharmacovigilance point of contact and key partner to country/region leadership
- Collaborate with quality, legal, marketing, commercial, communications, and other functions
- Establish and maintain the applicable country/region pharmacovigilance system
- Support regional process harmonization and innovation projects
- Promote awareness of and compliance with pharmacovigilance obligations
- Support responses to local pharmacovigilance-related regulatory requests
- Communicate global procedures and monitor implementation
- Participate in FDA interactions throughout the product life cycle
- Oversee US post-authorization requirements
- Review US aggregate reports and other pharmacovigilance documents
- Serve on the US Labelling Committee and review US labelling
- Lead preparation of Pharmacovigilance Agreements
- Review documentation related to outsourced activities
- Lead PSMF data collection in the country/region when needed
- Review documents for non-interventional studies and organized data collection systems
- Act as subject matter expert for GPS processes related to organized data collection
- Increase GPS team visibility across argenx
- Educate cross-functional teams on safety requirements and regulations
- Develop relationships related to adverse event reporting and pharmacovigilance activities
- Maintain knowledge of US regulations and evolving safety requirements
- Identify and communicate pharmacovigilance legislative updates
- Participate in GPS audit and inspection readiness and management
- Contribute to issue management and implement mitigation action plans
- Identify opportunities to align global pharmacovigilance standards
- Maintain knowledge of the company product portfolio and disease areas
- Contribute to pharmacovigilance KPIs
- Escalate issues to GPS leadership as appropriate
- Drive continuous improvement initiatives
- Perform other tasks as appropriate
Requirements
What you’ll need- Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field
- PharmD or MD is a plus
- At least 10-15 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities
- At least 8 years in pharmacovigilance/drug safety
- Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents
- Knowledge of the drug development process, GXP quality and compliance requirements
- Excellent presentation skills with the ability to communicate complex issues clearly
- Excellent planning and organizational skills with ability to manage competing priorities
- Excellent oral and written communication skills
- Strong ability to motivate, influence, and collaborate with multidisciplinary teams
- Ability to work independently and in a global environment
- Understanding of safety business processes and systems for the collections of adverse events
- Problem solving, conflict resolution and critical thinking skills
- Demonstrated ability to author or contribute to complex documents
- Proficiency with Microsoft Office Suite
- Fluency in written and spoken English
- Candidates must be located in the EST time zone
Benefits
Comp & perks- Short-term incentives program
- Long-term incentives program
- Equal consideration for employment without discrimination
- Inclusive work environment