Deputy Pharmacovigilance Officer

Job Description

As part of the clinical trials conducted by Epicentre/MSF on Ebola caused by the Bundibugyo virus (BDBV) in the Democratic Republic of Congo (DRC), and potentially in additional countries, the Deputy Pharmacovigilance Officer will provide operational, administrative, and technical support to the Pharmacovigilance Officer to ensure the effective implementation of the organization's safety surveillance activities.

The role contributes to the collection, assessment, documentation, and reporting of safety information in compliance with applicable regulatory requirements, internal procedures, ICH Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP) guidelines.

Main Activities

Under the supervision of the Pharmacovigilance Officer and in close collaboration with research teams, the Deputy Pharmacovigilance Officer will be responsible for the following activities:

1. Safety Data Collection & Case Management

• Receive safety information from study sites and perform an initial medical review to assess completeness, clinical consistency, and the need for follow-up.
• Liaise with investigators and site staff to obtain relevant follow-up information and clarify medical aspects of reported events.
• Enter safety information into the safety database and generate CIOMS reports.
• Perform MedDRA coding of adverse events.
• Contribute to SAE reconciliation activities between safety and clinical study databases.
• Escalate complex, medically significant, or potentially reportable safety issues to the Pharmacovigilance Officer and/or designated medical leads.

2. Pharmacovigilance Documentation & Reporting

• Prepare draft case narratives and support the preparation of regulatory reporting packages, including SUSAR reporting when required.
• Support the submission of safety reports to relevant stakeholders, including DSMBs, Ethics Committees, Investigational Product Manufacturers, Trial Steering Committees, and regulatory authorities, as applicable.
• Support the preparation of periodic safety reports.
• Contribute to the development and maintenance of pharmacovigilance documentation, including SOPs, work instructions, safety management plans, and study-specific procedures.

3. Compliance & Quality Support

In collaboration with the study monitor and according to the monitoring plan:

• Support the implementation of pharmacovigilance activities in accordance with GVP, ICH-GCP, study protocols, and applicable local regulatory requirements.
• Contribute to protocol deviation documentation and CAPA development, implementation, and follow-up.
• Support internal audits, inspections, and quality reviews related to pharmacovigilance activities.
• Participate in quality improvement initiatives to strengthen pharmacovigilance systems and processes.

4. Coordination & Communication

• Facilitate communication regarding safety procedures, reporting requirements, and pharmacovigilance updates.
• Support pharmacovigilance training activities for study staff, investigators, and partners.
• Conduct field visits when required and provide remote support to study teams involved in safety reporting and follow-up activities.
• Contribute to coordination between headquarters and field-based teams involved in the studies.

5. Operational & Administrative Support

• Maintain pharmacovigilance tracking tools, logs, dashboards, and filing systems.
• Organize pharmacovigilance meetings, prepare agendas, and draft meeting minutes.
• Support document archiving and inspection readiness activities.

Qualifications

Education & Experience

• Medical or paramedical background (MD preferred)" par "Medical, pharmacy or other health sciences background, with a strong applied clinical component. Experience in African settings is highly desirable.

• At least 2 years of relevant professional experience.
• Previous experience, including internships, in pharmacovigilance and/or clinical trials is strongly preferred.
• Additional training in Pharmacovigilance, Clinical Research, or Drug Safety would be an asset.

Technical Skills

• Good understanding of clinical research and pharmacovigilance principles.
• Familiarity with MedDRA coding and pharmacovigilance reporting requirements.
• Experience with safety databases and regulatory reporting processes would be a strong asset.
• Good command of Microsoft Office tools.

Languages

• Excellent written and spoken English and French (minimum C1 level in both languages).

Personal Skills

• Excellent written and verbal communication skills.
• Strong organizational skills and attention to detail.
• Ability to manage multiple priorities and work under tight timelines.
• Ability to work effectively within multidisciplinary and geographically dispersed teams.

Core Competencies

• Rigorous documentation and data management skills.
• Ability to work effectively with multidisciplinary and geographically dispersed teams.
• Strong interpersonal and coordination abilities.
• Commitment to participant safety and ethical research practices.
• Adaptability to fast-changing operational environments.
• Proactive and solution-oriented approach.

Additional Information

Employment Conditions

• Duty station: Paris (France) or Niamey (Niger), to be confirmed according to operational needs and the selected candidate profile.
• Contract duration: 12 months, renewable.
• Full-time position.
• Regular interaction with international study teams.
• Travel to study sites may be required.
• Salary and benefits will be determined according to Epicentre's employment conditions and salary scale applicable in the country of recruitment.

If the position is based in France, due to administrative constraints related to the contract duration, applicants must already be legally authorised to work in France at the time of application. Candidates must therefore either be citizens of a European Union member state or hold a valid residence permit allowing them to work in France.

Why Join Us?

• Contribute directly to innovative Ebola vaccine and therapeutic research conducted in humanitarian contexts.
• Support studies with a meaningful impact on patient safety and public health.
• Work within a multicultural and multidisciplinary research environment.
• Collaborate with teams based in several countries and operational settings.
• Have your ideas and contributions valued within a dynamic and growing organization.
• Develop expertise in pharmacovigilance and clinical research within a unique humanitarian framework. 

• How to apply : Please submit your application (CV and cover letter) no later than 15 November 2026.

We value diversity and strive to maintain an inclusive and accessible working environment. We encourage all individuals who meet the required qualifications to apply, regardless of their ethnic, national, or cultural background, age, gender, sexual orientation, religious beliefs, disability, or any other aspect of their identity.

Epicentre is committed to protecting the personal data of its members, employees, and applicants. The data collected during the recruitment process will be accessed exclusively by individuals involved in the recruitment procedure and processed solely for recruitment purposes, ensuring fairness, confidentiality, and high-quality handling, regardless of the Epicentre structure to which they belong.