Africa Clinical Research Network (ACRN) is an African-led clinical research organization building the next generation of trial capacity across the continent. We work with existing hospitals, research units, and investigators to enable high-quality clinical research—from investigator-initiated studies to late-phase and registration trials—while strengthening local systems, skills, and infrastructure.
ACRN operates as a pan-African site management and research delivery platform, combining strong clinical operations, regulatory expertise, data and digital systems, and quality management. Our model is practical and embedded: we focus on making trials work in real settings, reducing friction for sites, sponsors, and regulators, and delivering reliable, audit-ready data.
We partner closely with governments, regulators, academic institutions, and industry to expand Africa’s role in global clinical research, while ensuring that studies generate local value—through workforce development, institutional strengthening, and improved patient care.
At ACRN, you’ll work on meaningful, complex projects with global impact, alongside a multidisciplinary team that values rigor, accountability, and innovation. We are building something durable, ambitious, and distinctly African—and we are looking for people who want to help shape it.
About the role
The Pharmacovigilance Officer (IC2) is responsible for the execution of day-to-day drug safety activities across ACRN’s clinical research portfolio, ensuring protection of participant safety and compliance with global pharmacovigilance requirements. The role focuses on the collection, assessment, processing, and reporting of adverse events (AEs) and Individual Case Safety Reports (ICSRs) arising from clinical trials.
What you'll do
1. Case Intake, Processing, and ICSR Management
• Collect, review, and process adverse events and safety information from clinical trials and other approved sources.
• Enter, update, and maintain Individual Case Safety Reports (ICSRs) in validated safety databases.
• Ensure timely and accurate case processing in accordance with SOPs and regulatory timelines.
2. Medical Coding and Data Quality Control
• Perform MedDRA and WHODD coding of adverse events, indications, and medicinal products.
• Conduct quality checks on case data, narratives, and attachments prior to submission.
• Ensure data completeness, consistency, and traceability across safety records.
3. Safety Reporting Support (Expedited and Periodic)
• Support preparation and submission of expedited safety reports (e.g., SUSARs) to regulators, ethics committees, and sponsors under supervision.
• Contribute to periodic safety reports, listings, and summaries.
• Support reconciliation of safety data with clinical and regulatory datasets.
4. Safety Database Operations
• Maintain safety database records and support routine system checks.
• Support controlled updates, user access, and documentation related to safety systems.
• Generate standard safety listings, metrics, and reports as required.
5. Literature Monitoring and Safety Surveillance
• Screen scientific and medical literature for safety-relevant information related to investigational products.
• Document findings and escalate relevant safety information in accordance with SOPs.
6. Regulatory Compliance and Inspection Readiness
• Ensure pharmacovigilance activities comply with applicable regulations and guidelines, including ICH, FDA, EMA, and local authority requirements.
• Maintain inspection-ready pharmacovigilance documentation at all times.
• Support audits and regulatory inspections by retrieving records and explaining processes as required.
7. Cross-Functional Collaboration and Escalation
• Work closely with Medical, Clinical Operations, Data Management, Quality Assurance, Regulatory Affairs, and IT teams.
• Escalate safety concerns, medical judgment questions, or compliance risks to senior safety or medical leadership.
• Support safety training and awareness activities for study teams when required.Describe the specific responsibilities and job functions of the role
Qualifications, Skills & Experience
Minimum Qualifications
• Bachelor’s degree in Pharmacy, Life Sciences, Medicine, Nursing, or a related field.
Preferred Qualifications
• Formal training or certification in pharmacovigilance or drug safety.
Required Experience
• 1–3 years’ experience in pharmacovigilance, drug safety, or regulated clinical research environments.
• Hands-on experience with ICSR processing and safety database use.
Preferred Experience
• Familiarity with MedDRA and WHODD coding.
• Experience supporting regulatory safety reporting in clinical trials.
Core Competencies
• High attention to detail and data accuracy.
• Strong understanding of pharmacovigilance workflows and timelines.
• Ability to follow SOPs and regulatory guidance precisely.
• Clear written and verbal communication skills.
• Professional judgment in escalation of safety issues.
Application Deadline: 27 February 2026
PI639a4f70bced-37437-39722106
