Safety Aggregate Report Manager / Senior PV Scientist – IQVIA
Job Details
- Company: IQVIA
- Position: Safety Aggregate Report Manager / Senior PV Scientist
- Location: Bloemfontein, South Africa
- Employment Type: Full-time
- Workplace Type: Hybrid
- Job Reference: R1570557
- Industry: Life Sciences / Healthcare
- Job Function: Pharmacovigilance
Job Overview
IQVIA is seeking a Safety Aggregate Report Manager / Senior Pharmacovigilance (PV) Scientist to serve as a global functional lead for Safety Aggregate Report and Analytics (SARA) projects.
The role involves leading and overseeing safety aggregate reports, literature surveillance, signal management and benefit-risk management activities. The successful candidate will work with global project teams and clients while ensuring deliverables meet regulatory requirements, quality standards and strict timelines.
Key Responsibilities
Aggregate Reporting
- Serve as a global functional lead for aggregate reporting, signal management and literature surveillance projects.
- Lead, author and finalise safety aggregate reports, including:
- PBRERs/PSURs
- DSURs
- PADERs
- RMPs
- REMS
- ACOs
- Line listings
- Prepare responses to regulatory agencies and Pharmacovigilance Risk Assessment Committee (PRAC) inquiries where required.
- Oversee and conduct quality checks of SARA deliverables.
- Ensure final deliverables meet client, IQVIA and regulatory requirements.
Literature Surveillance
- Act as literature lead, backup lead or reviewer/QC.
- Conduct ongoing literature safety surveillance for marketed and investigational products.
- Assist with identification of Individual Case Safety Reports (ICSRs) from literature.
- Evaluate events of special interest and assess aggregate data or signal-detection relevance.
- Author and contribute to literature deliverables within regulatory timelines.
Signal Management
- Lead signal-management activities for complex post-marketing and clinical trial projects.
- Establish and coordinate safety management teams.
- Develop and maintain product signalling strategies.
- Apply complex data-mining methodologies and algorithms to internal and external safety data.
- Conduct signal detection, validation and evaluation activities.
- Track and document signals and associated risks.
- Prepare metrics and KPIs and support audits and inspections.
Regulatory & Compliance
- Lead or review safety responses to regulatory agencies and PRAC.
- Prepare justification documents supporting product labelling.
- Ensure compliance with applicable SOPs and Good Documentation Practices (GDP).
- Maintain project files and contact lists in accordance with SOP requirements.
- Participate in internal and external audits and support audit-readiness activities.
- Ensure required training is completed and documented.
Team Leadership & Mentoring
- Provide training to SARA staff.
- Mentor and coach project team members and direct reports.
- Support less experienced staff through training and knowledge sharing.
- Lead functional teams and contribute to departmental productivity and utilisation objectives.
- Support resource planning and allocation according to workload and reporting requirements.
Project & Stakeholder Management
- Work closely with clients and internal teams across Lifecycle Safety and other IQVIA business units.
- Provide regular project updates covering metrics, scope changes, client requests and concerns.
- Communicate project issues to project teams and management.
- Participate in project review meetings.
- Act as an interface between global project leads and working teams.
- Conduct lessons-learned sessions and ensure relevant information is shared with team members.
Continuous Improvement
- Identify and implement process efficiencies.
- Participate in working groups and operational initiatives.
- Contribute to SOP reviews.
- Proactively identify issues and recommend solutions.
- Drive continuous improvement across SARA services.
Minimum Requirements
Qualifications
- Life Sciences graduate/postgraduate qualification, Pharmacy, Nursing or another healthcare-related qualification.
- Relevant pharmacovigilance experience may also be considered.
Experience
- 5–10 years of relevant Pharmacovigilance experience.
- Hands-on experience in drug safety is required.
- Experience with aggregate reports, signal detection and/or signal management is preferred.
Key Skills
- Strong written and verbal communication.
- Excellent organisational and time-management skills.
- Ability to meet strict regulatory deadlines.
- Ability to manage competing priorities.
- Flexibility in responding to changing project requirements.
- Strong pharmacovigilance and drug-safety knowledge.
- Aggregate safety reporting.
- Signal detection and management.
- Literature surveillance.
- Regulatory compliance.
- Team leadership and mentoring.
- Fluent English, both written and spoken.
About IQVIA
IQVIA provides clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The company supports the development and commercialisation of innovative medical treatments and works across global healthcare and life-sciences markets.