Job Description

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.