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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance agreements, regulatory compliance, and stakeholder management, with a strong focus on patient safety and quality assurance. Proficient in navigating global pharmacovigilance regulations and fostering partnerships across diverse teams and organizations.
Highest-signal resume keywords
Pharmacovigilance Agreements ManagementGlobal Pharmacovigilance RegulationsRegulatory Compliance ExpertiseProject Management SkillsStakeholder Engagement
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 Impact AssessmentsNegotiation SkillsCompliance MonitoringMedicinal Product Management
Soft Skills
Strong CommunicationOrganizational SkillsInfluencing AbilitiesCollaborative Team PlayerAttention to Detail
Tools & Technologies
Microsoft Office ApplicationsPharmacovigilance Systems
Industry Keywords
Life SciencesPharmacyMedicinePatient SafetyCommercial Pharmaceutical Environment
About the role
Key responsibilities & impact- Oversee the lifecycle of pharmacovigilance agreements and partnerships.
- Ensure compliance with global pharmacovigilance requirements and support safe and effective management of medicinal products across international markets.
- Lead the development, negotiation, implementation and maintenance of pharmacovigilance agreements and partnerships.
- Serve as the subject matter expert for global pharmacovigilance regulatory requirements and regulatory intelligence activities.
- Monitor and assess evolving pharmacovigilance legislation and guidance, identifying impacts to business processes and compliance obligations.
- Coordinate cross-functional implementation of regulatory changes and monitor ongoing compliance.
- Develop and maintain a global network of pharmacovigilance partners and consultants.
- Provide oversight of partner compliance, including participation in audits, governance meetings and corrective action management.
- Support clients and internal stakeholders with expert advice on pharmacovigilance requirements, including early access and unlicensed medicine programmes.
- Build and maintain relationships with clients, alliance partners, industry associations and regulatory authorities.
Requirements
What you’ll need- Bachelor's degree in Life Sciences, Pharmacy, Medicine or a related scientific discipline.
- Significant experience within pharmacovigilance, including knowledge of global pharmacovigilance regulations and requirements.
- Experience negotiating and managing pharmacovigilance agreements and external partnerships.
- Strong understanding of pharmacovigilance legislation and regulatory compliance requirements.
- Experience conducting regulatory impact assessments and implementing regulatory changes.
- Excellent project management, organisational and stakeholder management skills.
- Strong communication, negotiation and influencing abilities.
- Ability to work effectively across global, cross-functional teams.
- Proficiency with Microsoft Office applications and relevant pharmacovigilance systems.
- Desirable: Experience within early access, compassionate use or unlicensed medicines programmes.
- Desirable: Experience working within a commercial pharmaceutical environment.
- Desirable: Experience supporting alliance management, partner governance or international vendor management activities.
- Desirable: Knowledge of pharmacovigilance regulatory intelligence processes and tools.
- Desirable: Experience working in a global or multicultural environment.
- A proactive and solutions-focused approach.
- Strong attention to detail and commitment to quality and compliance.
- Ability to manage multiple priorities in a fast-paced and evolving environment.
- A collaborative team player with the confidence to influence and engage stakeholders at all levels.
- Passion for patient safety and maintaining high standards of pharmacovigilance compliance.