Specialist Pharmacovigilance ICSR Unit

Location:
Tunisia Employment type: Contract Working pattern: Remote

About the Role
We are seeking a Specialist Pharmacovigilance Case Processing professional to support the accurate, timely and compliant management of individual case safety reports and other safety information. You will work across a range of pharmacovigilance activities, including case intake, data entry, quality review, follow-up, reconciliation and compliance monitoring. You will collaborate with internal teams, external partners and other stakeholders to ensure safety information is managed in accordance with applicable regulations, procedures and quality standards. This is an opportunity to join a collaborative environment where you can contribute to process improvements, support inspection readiness and help maintain high standards of patient safety and regulatory compliance.

Key Responsibilities

- Receive, triage and assess potential pharmacovigilance and other safety reports.
- Identify and process individual case safety reports from multiple sources.
- Conduct duplicate searches and enter cases accurately into the relevant safety database.
- Perform case quality checks and support the resolution of data-quality issues.
- Transmit cases to relevant databases, partners or authorised recipients within required timelines.
- Anonymise, record and archive source documentation in accordance with applicable requirements.
- Conduct follow-up with reporters and other sources to obtain additional information.
- Respond to requests for clarification, further information or translation.
- Support periodic safety-data reconciliations and investigate discrepancies.
- Monitor compliance with regulatory and procedural submission timelines.
- Support the identification and management of deviations and corrective and preventive actions.
- Contribute to audits, inspections and inspection-readiness activities.
- Participate in the development and maintenance of procedures, training materials and quality documents.
- Identify and implement opportunities to improve pharmacovigilance processes.
- Provide support for business continuity and cover arrangements when required.
- Act as a subject matter expert or deputy subject matter expert for selected activities, where assigned. About You You will have:
- At least two years’ experience in an industry pharmacovigilance role.
- Practical experience in individual case safety report processing.
- Knowledge of pharmacovigilance regulations, case-management processes and compliance requirements.
- Experience using safety databases or case-management systems.
- Strong attention to detail and a commitment to data quality.
- Excellent organisational and time-management skills.
- The ability to prioritise work and meet regulatory and procedural deadlines.
- Strong written and verbal communication skills in English and French.
- A collaborative and flexible approach to working.
- The ability to manage confidential and sensitive safety information appropriately.
- A degree or equivalent qualification in a health science, life science, medical science, pharmacy, nursing or related discipline.
- Experience in reconciliation, compliance monitoring, audits, inspections, corrective and preventive actions, process improvement or working with external partners would be advantageous.

What We Offer

- The opportunity to contribute to important patient-safety and public-health activities.
- A collaborative and supportive working environment.
- Exposure to a broad range of pharmacovigilance processes and projects.
- Opportunities to develop technical, regulatory and stakeholder-management skills.
- Support for continuous learning and professional development.

How to Apply
If you have the required pharmacovigilance experience and are interested in developing your career in safety case processing, please submit your CV.