Pharmacovigilance Officer W/M

SERB Pharmaceuticals; Paris; Sur place; EUR 55 000 - 90 000; Plein temps

Avantages offerts par ce poste

Competitive compensation

Equal opportunity employer

Collaborative culture

Résumé du poste

SERB Pharmaceuticals in Paris is seeking an experienced Pharmacovigilance Officer to join the vigilance department. You will manage routine PV case processing, participate in signal management, and support audits and inspections to ensure compliance.

The role requires a scientific background, at least 3 years in pharmacovigilance, and proficiency with safety databases. Strong medical English and collaboration across departments are essential.

Qualifications

• At least 3 years’ experience in vigilance activities (pharmacovigilance, materiovigilance, etc.)
• Knowledge of safety databases and PV tools
• Proficiency in medical English for reading, writing, and translating data

Responsabilités

• Participate in PV routine case management and reconciliations with partners
• Contribute to signal management, aggregate reports, RSI/RFI
• Support audits and inspections and ensure CAPAs and deviations are tracked

Connaissances

PV case analysis

Interdepartmental collaboration

Medical English

Formation

Scientific graduation

Outils

Safety databases

PV databases

Description du poste

Critical Needs. Immediate Action. SERB is a fast-growing global specialty pharma company designed to address rare and urgent conditions by delivering life-saving medicines when time and complexity leave no room for failure.

Critical Needs. Immediate Action. SERB is a fast-growing global specialty pharma company designed to address rare and urgent conditions by delivering life-saving medicines when time and complexity leave no room for failure. We operate end-to-end across 100+ countries, ensuring 70+ essential medicines for rare diseases, emergency care, and medical countermeasures reach patients and clinicians with urgency – wherever and whenever they are needed. Shaped over the past 25 years by an entrepreneurial, disruptive spirit, SERB combines the focus and agility of a biotech with the scale, reach, and reliability of a global pharmaceutical company — always grounded in medical purpose, not corporate convention. Our 600+ employees are driven by three core values:

• Patients first, always Patients are not a concept — they are why we act, especially when time matters most.
• Impact focused We are agile, entrepreneurial, and disciplined - working smart and learning continuously to deliver results that matter, with the consistency, quality, and trust that critical care demands.
• Team powered We go the extra mile - together - because our shared commitment drives extraordinary outcomes.

Guided by a clear ambition and a relentless focus on patients, SERB continues to expand through selective, innovative acquisitions, launching new treatments and entering new geographies. Across every step — from integration to delivery — our people act with passion, ownership, and determination to ensure life-saving medicines become available to patients who need them, worldwide. The vigilance department encompasses activities such as case management, risk management, PSMFs maintenance, contractual agreements maintenance, signal management, audits & inspections and their follow up actions, aggregate reports drafting, medical device vigilance activities, Literature search, Labelling committee, projects.

As a Pharmacovigilance Officer, your responsibilities will include:

• Participation to all the PV routine case management activities: internal & external reconciliations, exchange of PV cases with partners, acknowledgment of receipt, transfer of PV cases to the PV provider; etc.
• Participation to all the department activities such as (but not limited to): signal management, aggregate reports, RSI/RFI
• Participates in vigilance data migration activities following the acquisition of new pharmaceutical products and/or companies. Drafting of the protocols and migration reports.
• Contributes to quality activities relating to Vigilance processes:
• Drafting and updating of quality documents
• Implementation and follow-up of CAPAs, Change Control, deviations
• Participation in audits and inspections (back & front rooms, as necessary);
• Participation in the risk analysis of the partners annually to set up the audit schedule for the vigilance department
• Participation to the annual risk analysis for the service providers including the vigilance relevant vendors
• Participation in the elaboration and update of SDEAs/PVAs with partners
• Participation in the maintenance of the PSMF and its appendices;
• Participation to Medical Device activities
• Participation to transversal activities with other SERB departments (in particular regulatory affairs, quality assurance, commercial, sales and marketing, legal, finance, HR, etc.) :
• Validation of promotional material (when needed)
• Review and validation of product information
• Budget review where applicable
• Validation of the vigilance service providers and partners invoices

To be successful in this role, you should demonstrate:

• EDUCATION / PROFESSIONAL EXPERIENCE
• Scientific graduation
• At least 3 years’ experience in vigilance activities (pharmacovigilance, Materiovigilance, etc.)
• Knowledge of safety database
• PROFESSIONAL SKILLS
• Ability to review, interpret and analyze PV/MV cases
• Proficiency in medical English to read, write and translate scientific and medical data
• Knowledge of GVP modules (EU/UK), 21CFR
• Mastery of IT tools, in particular safety databases - Good management of random workload
• PERSONAL SKILLS
• Rigor
• Autonomy
• Good inter-departmental relationship
• Likes team work

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.