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Posted: 10/20/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Drug Safety and Pharmacovigilance, with a strong focus on ICSR processing, regulatory compliance, and quality improvement initiatives. Proficient in leading process change management and supporting cross-functional teams in achieving operational excellence.
Highest-signal resume keywords
Drug Safety ExperiencePharmacovigilance ProceduresICSR ProcessingRegulatory InteractionUser Acceptance Testing
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Define, design, write, maintain, and improve global case processing standards, processes, and data handling conventions
- Assess end-to-end ICSR processes to identify gaps, inefficiencies, compliance risks, and improvement opportunities
- Partner with Case Processing Oversight to analyze quality trends and drive continuous improvement initiatives
- Define and maintain business requirements for ICSR intake and case processing activities and support implementation with systems and IT teams
- Conduct impact assessments and User Acceptance Testing (UAT) for safety system enhancements and changes
- Support SOPs, job aids, training content, inspection readiness activities, audits, and health authority interactions
- Lead process change management, communications, and training related to new or revised standards and procedures
- Support cross-functional quality, compliance, and operational excellence initiatives
Requirements
What you’ll need- Bachelor's degree in Nursing, Pharmacy, Life Sciences, or related health discipline
- Minimum 5 years of Drug Safety or Pharmacovigilance experience in pharmaceutical, biopharmaceutical, or CRO environments
- Working knowledge of pharmacovigilance, ICSR processing, GCP, and GVP requirements
- Experience authoring and maintaining pharmacovigilance procedures and process documentation
- Ability to interpret regulatory requirements and assess operational impacts
- Experience translating business needs into system requirements and supporting validation activities
- Experience supporting safety system enhancements and UAT activities preferred
- Inspection readiness, audit support, and regulatory interaction experience preferred
- Experience working with cross-functional global project teams preferred
- Advanced degree in a relevant scientific discipline preferred
Benefits
Comp & perks- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
- Short term and long-term incentives, including cash bonus and equity incentive opportunities
- Hybrid work arrangement preference; remote work may be available for highly qualified candidates residing within the United States
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Case Processing StandardsImpact AssessmentsProcess DocumentationRegulatory Requirements InterpretationContinuous Improvement InitiativesTraining Content DevelopmentAudit SupportInspection ReadinessGCP KnowledgeGVP Knowledge
Soft Skills
CommunicationCollaborationLeadership
Industry Keywords
PharmaceuticalBiopharmaceuticalCROHealth Authority InteractionsCross-Functional TeamsQuality Trends AnalysisOperational Excellence