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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Pharmacovigilance, particularly in Case Processing and Case Management, with strong analytical and organizational skills. Proficient in MedDRA coding, quality control, and collaboration with global teams in compliance with regulatory standards.
Highest-signal resume keywords
Pharmacovigilance Case ProcessingMedDRA CodingArgus Safety DatabaseGlobal Pharmacovigilance RegulationsQuality Control and Review
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
PharmacovigilanceCase ManagementMedDRA CodingQuality ControlData Entry VerificationRoot Cause AnalysisCAPA DevelopmentQuality AssessmentSafety Data Exchange AgreementsPharmacovigilance Agreements
Soft Skills
Analytical SkillsOrganizational SkillsProblem-Solving SkillsCommunication SkillsCollaboration Skills
Tools & Technologies
Argus SafetyMicrosoft Office
Industry Keywords
EMAFDAMHRAPMDAHealth CanadaICH E2BGVPCIOMS
About the role
Key responsibilities & impact- Act as a point of contact for case processing vendors and respond to operational queries related to case management activities
- Monitor case processing timelines and identify root causes of delays in case reporting and submissions
- Perform regular quality reviews of pharmacovigilance cases, including data entry verification, MedDRA coding review, narrative review and quality assessment, and consistency checks against source documentation
- Manage and track corrections, clarifications, and follow-up requests with external partners and vendors
- Review and approve quality control activities for assigned products and studies
- Support pharmacovigilance case reconciliation activities with business partners and external service providers in accordance with Safety Data Exchange Agreements and Pharmacovigilance Agreements
- Contribute to deviation management activities, including Root Cause Analysis, CAPA development, and continuous quality improvement initiatives
- Collaborate closely with Pharmacovigilance Quality, Global Safety Operations, and cross-functional stakeholders
Requirements
What you’ll need- Bachelor's degree or higher in Pharmacy, Life Sciences, Nursing, Medicine, or a related scientific discipline
- Solid experience in Pharmacovigilance with strong expertise in Case Processing and Case Management
- Hands-on experience with Argus Safety or equivalent safety databases
- Strong knowledge of global pharmacovigilance regulations and guidelines, including EMA, FDA, MHRA, PMDA, Health Canada, ICH E2B, MedDRA, GVP, and CIOMS
- Excellent MedDRA coding and narrative writing skills
- Experience performing quality control and quality review of safety cases
- Familiarity with vendor management and outsourced pharmacovigilance activities
- Strong analytical, organizational, and problem-solving skills
- Ability to manage multiple priorities in a fast-paced international environment
- Excellent communication skills and ability to collaborate with global teams
- Proficiency in Microsoft Office tools
- Fluent English, written and spoken
Benefits
Comp & perks- Opportunity to grow through diverse and stimulating projects
- Collaboration with leading experts
- Contribution to scientific, operational, and human knowledge
- Environment that values natural talents, encourages boldness, pushes boundaries, and cultivates potential
- Teamwork-focused culture
- Employee experience focus