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Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance processes, including ICSR management, regulatory compliance, and data reporting. Proficient in handling safety reports, coding, and supporting quality assurance activities within the healthcare sector.
Highest-signal resume keywords
Pharmacovigilance ExperienceICSR ManagementMedDRA CodingAdvanced English ProficiencyMS Office Literacy
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 activities within the ICSR management unit within agreed scope and timelines
- Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, company procedures, client requirements and timelines
- Perform ICSR follow-up, SAE/SUSAR management, including unblinding, clinical trial reconciliation, protocol review and Safety Management Plan review
- Perform clinical and partner reconciliation
- Handle personal data protection and Product Quality Complaints
- Interact with Quality Assurance and Medical Information
- Perform MedDRA and WHO coding
- Produce database outputs and reports, including data for monthly client reporting
- Support workflow and resource management
- Support pharmacovigilance processes related to ICSR management for PrimeVigilance and clients
- Perform tasks assigned under SOPs to more junior positions, as applicable to senior colleagues
- Support the RA & PV Network Department as needed
- Act as LCPPV for the specified country and PRLS for the designated language, as agreed with the line manager
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
- English - advanced (spoken, written)
- Advanced literacy (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
- Equal opportunities workplace
- Human-centric environment
- Employee experience, well-being and mental health emphasis
- Work-life balance emphasis
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/SUSAR ManagementClinical Trial ReconciliationSafety Management Plan ReviewData ReportingDatabase Output ProductionPersonal Data ProtectionProduct Quality Complaint HandlingProtocol ReviewWorkflow Management
Soft Skills
Organization SkillsAttention to DetailMultitaskingTime ManagementIssue Management
Industry Keywords
Life ScienceHealthcarePharmacovigilanceQuality AssuranceMedical InformationRegulatory ComplianceClient ReportingSOPsLCPPVPRLS