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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates advanced knowledge of Pharmacovigilance and proficiency in PV systems such as Oracle Argus Safety and ARISg. Capable of leading and mentoring teams while ensuring compliance with safety regulations and internal guidelines.
Highest-signal resume keywords
Pharmacovigilance ExpertiseLeadership ExperienceProject Management SkillsOracle Argus SafetyAttention to Detail
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 ProcessingAdverse Event IntakeQuality ControlProcess ImprovementTraining DevelopmentRegulatory CompliancePerformance FeedbackWorkflow DevelopmentClient Communication
Soft Skills
Verbal CommunicationWritten CommunicationInterpersonal SkillsProblem-SolvingTeamwork
Tools & Technologies
Oracle Argus SafetyARISgSafety Databases
Certifications & Qualifications
Bachelor's Degree in Life SciencesAdvanced Degree (Preferred)RN (Preferred)RPh (Preferred)PharmD (Preferred)
Industry Keywords
Pharmacovigilance ActivitiesSOPsGlobal Safety RegulationsCase ManagementPerformance Reviews
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- Supervise PV staff and provide oversight of pharmacovigilance activities, processes and procedures
- Oversee adverse event intake and case processing
- Ensure PV activities are processed consistently with internal guidelines, SOPs and global safety regulations
- Collaborate with PV management to coordinate, develop and maintain ProPharma's pharmacovigilance services
- Act as client contact for case management communications
- Participate in process, workflow and supporting-document development and continuous improvement
- Provide oversight and direction as a PV subject matter expert
- Supervise workload, provide performance feedback and conduct annual reviews
- Lead, coach, mentor and motivate staff
- Handle hiring, scheduling and training responsibilities
- Foster teamwork, resolve conflicts and communicate departmental needs to management
- Review cases for training feedback and ensure regulatory compliance
- Maintain and update work instructions, training materials and templates
- Identify and address PV staff training needs
- Support client implementation through meetings, guideline creation and process explanation
- Perform billable case processing, quality-control case review, inbox assistance or other case-processing activities
Requirements
What you’ll need- Bachelor's degree in life sciences or an equivalent combination of relevant education and work experience
- Five years of related work experience
- One year of leadership experience
- Strong verbal, written and interpersonal communication skills with clients, external and internal staff
- Excellent project management skills
- High level of accuracy and attention to detail
- Excellent problem-solving skills and ability to resolve problems in a timely manner
- Ability to work independently and collaboratively in a multi-disciplinary team
- Excellent organization and prioritization skills with attention to detail
- Advanced knowledge of Pharmacovigilance
- Advanced knowledge of PV systems, such as Oracle Argus Safety, ARISg, or other safety databases
- Self-motivated to maintain high efficiency and productivity levels and manage multiple projects and clients
- Preferred: an advanced degree, RN, RPh, PharmD or equivalent
- Preferred: one year of people management experience
Benefits
Comp & perks- Remote working support
- Hybrid working option for new hires based within a reasonably short commute of an office, as agreed with the manager
- Equal Opportunity Employer workplace committed to diversity, equity, and inclusion
