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Core Competencies
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 safety reporting. Proficient in mentoring and training team members while ensuring effective communication and organization within project teams.
Highest-signal resume keywords
Pharmacovigilance ExpertiseICSR ManagementMedDRA CodingRegulatory ComplianceTeam Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Individual Case Safety Report ProcessingSAE/SUSAR ManagementClinical Trial ReconciliationSafety Management Plan ReviewProduct Quality Complaint HandlingDatabase ReportingPharmacovigilance ProcessesTechnical Skills
Soft Skills
Excellent Communication SkillsOrganization SkillsAttention to DetailMultitaskingDelegation SkillsPlanning and Time ManagementTeam Working
Tools & Technologies
MS Office
Industry Keywords
Life SciencePharmacyHealthcarePharmacovigilanceLocal Contact Person for PharmacovigilancePerson Responsible for Local Screening
About the role
Key responsibilities & impact- Provide support to project team activities on behalf of clients and the company
- Process Individual Case Safety Reports (ICSRs) from all sources in compliance with regulations, procedures, client requirements, and timelines
- Perform ICSR follow-up, including SAE/SUSAR management, unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review
- Perform clinical and partner reconciliation
- Manage personal data protection activities
- Handle Product Quality Complaints and interact with Quality Assurance
- Interact with Medical Information teams
- Perform MedDRA and WHO coding
- Produce database outputs and reports, including monthly client reporting data
- Manage workflow and resources
- Mentor and train new and junior employees
- Support pharmacovigilance processes for PrimeVigilance and clients
- Support or contribute as an ICSR Subject Matter Expert
- Support the RA & PV Network Department as needed
- Act as Local Contact Person for Pharmacovigilance (LCPPV) for a specified country and Person Responsible for Local Screening (PRLS) for a 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
- 10–12 years of work experience in pharmacovigilance
- Excellent written and verbal communication skills
- Organization skills, including attention to detail and multitasking
- Delegation skills
- Planning and time management
- Technical skills
- Team working
- Fluent spoken and written English
- Advanced literacy in MS Office
Benefits
Comp & perks- Remote work option
- Collaborative and supportive team environment
- Flexible work culture
- Growth opportunities
- Belonging and inclusive workplace culture
- Passionate team of experts in clinical research, pharmacovigilance, and quality consulting