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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in ICSR management, including processing Individual Case Safety Reports and managing SAEs/SUSARs, while ensuring compliance with regulations and client requirements. Proficient in data management and reporting, with strong organizational and communication skills.
Highest-signal resume keywords
ICSR ManagementPharmacovigilance ExperienceMedDRA CodingAdvanced English ProficiencyMS Office Literacy
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
ICSR ProcessingSAE ManagementClinical Trial ReconciliationSafety Management Plans ReviewData ReportingProduct Quality Complaint HandlingPersonal Data ProtectionProtocol ReviewWHO CodingWorkflow Management
Soft Skills
Organization SkillsAttention to DetailMultitaskingTime ManagementIssue Management
Industry Keywords
PharmacovigilanceLife SciencesHealthcareClinical TrialsQuality AssuranceMedical InformationRegulatory ComplianceClient ReportingSafety ManagementData Protection
About the role
Key responsibilities & impact- Provide support to other activities undertaken by the project team on behalf of the client and the company
- Perform ICSR management activities within agreed scope and timeframe
- Process Individual Case Safety Reports from all sources in compliance with applicable regulations, company procedures, client requirements and timelines
- Perform ICSR follow-up activities
- Manage SAEs/SUSARs, including unblinding, clinical trial reconciliation and protocol review
- Review Safety Management Plans
- Perform clinical and partner reconciliation
- Handle personal data protection activities
- Handle Product Quality Complaints and interact with Quality Assurance
- Interact with Medical Information
- Perform MedDRA and WHO coding
- Prepare database outputs and reports, including monthly client reporting data
- Support workflow and resource management
- Support PV processes related to ICSR management for PrimeVigilance and clients
- Support the RA & PV Network Department as needed
- Act as LCPPV for the specified country when assigned
- Act as PRLS for the designated language when assigned
Requirements
What you’ll need- Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
- Minimum 1 year of work experience in pharmacovigilance
- Organization skills, including attention to detail and multitasking
- Management skills, including time and issue management
- Advanced English, spoken and written
- Advanced literacy in MS Office
Benefits
Comp & perks- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world
- English as the company language
- Equal opportunities workplace
- Human-centric environment
- Focus on employee experience, well-being and mental health
- Healthy work-life balance