Pharmacovigilance Scientist -IQVIA x2
JOB DETAILS
- Position: Pharmacovigilance Scientist 2
(Safety Aggregate Report Specialist 2) - Location: Bloemfontein, South Africa (Hybrid)
- Employment Type: Full-time, Hybrid work model
- Company: IQVIA
- Industry: Healthcare, Clinical Research, Drug Safety (Pharmacovigilance)
- JOB DESCRIPTION
The Pharmacovigilance Scientist 2 is responsible for monitoring, evaluating, and reporting the safety of pharmaceutical products.
This role focuses on:
- Detecting and analysing safety signals
- Writing and managing aggregate safety reports
- Ensuring compliance with global regulatory requirements
- Leading safety activities for assigned products (molecules)
It is a mid-to-senior level role requiring strong experience in drug safety, data analysis, and regulatory reporting.
KEY RESPONSIBILITIES
1. Signal Detection & Safety Surveillance
- Lead or support literature safety surveillance
- Identify and evaluate safety signals
- Analyse events of special interest and aggregate data
- Perform signal validation and risk assessment
2. Aggregate Report Writing
- Author and finalize key regulatory reports, including:
- PBRERs / PSURs
- DSURs
- ACOs
- Ensure reports are accurate, compliant, and submitted on time
3. Regulatory Communication
- Prepare responses to regulatory authorities and PRAC inquiries
- Ensure compliance with global pharmacovigilance regulations
4. Molecule (Product) Leadership
- Act as molecule lead (main responsible person for a product)
- Manage end-to-end safety activities for assigned products
- Develop and update signal detection strategies
- Track safety signals from identification to reporting
5. Team Coordination
- Allocate and manage workload across team members
- Collaborate with cross-functional teams (clinical, regulatory, etc.)
- Support team during high workload periods
6. Quality & Compliance
- Ensure high-quality deliverables aligned with KPIs
- Follow standard operating procedures (SOPs)
- Participate in audits and inspections
7. Documentation & Reporting
- Maintain full documentation of safety signals
- Ensure proper tracking and reporting processes
- Conduct “lessons learned” sessions with teams
REQUIREMENTS
Qualifications
- Degree in:
- Life Sciences
- Pharmacy
- Nursing
- Or related healthcare field
Experience
- 4–6 years’ experience in Pharmacovigilance
- Hands-on experience in:
- Drug safety
- Aggregate report writing
- Signal detection and management
Skills
- Strong written and verbal communication
- Excellent analytical and problem-solving skills
- Ability to work in teams and lead when required
- Fluent in English
KEY COMPETENCIES
Technical Skills
- Pharmacovigilance and drug safety expertise
- Signal detection and risk assessment
- Regulatory reporting knowledge
Professional Skills
- Strong writing and documentation skills
- Attention to detail and accuracy
- Project and workload management
Personal Attributes
- Team-oriented
- Responsible and accountable
- Ability to work under pressure and deadlines
ABOUT THE ROLE
This role is critical in ensuring that medicines are safe for public use by:
- Monitoring risks
- Identifying safety concerns early
- Supporting regulatory decision-making
IMPORTANT NOTES
- Requires specialised experience in pharmacovigilance
- Strong emphasis on regulatory compliance and accuracy
- All application information must be truthful and complete