Drug Safety Officer

Drug Safety Officer

Biogen

Paris, France

About This Role

As Drug Safety Officer, you will monitor the safety of products marketed in France or used in Early Access Programs (EAP) to guarantee patients’ safety and the application of regulations. You will be the contact person for the company's customers (healthcare professionals and patients) about pharmacovigilance (PV) and medical information.

What You'll Do

• Monitor and assess the benefit–risk profile of company products, ensuring continuous pharmacovigilance compliance;
• Collect, document, evaluate, follow up, and archive pharmacovigilance cases, ensuring high-quality data entry and case processing in line with regulations;
• Lead local signal detection, off-label use analysis, and PML-related activities, collaborating closely with global safety teams (SABR);
• Act as local Pharmacovigilance Safety Expert and serve as Deputy Responsible Pharmacovigilance (RPV) in the absence of the RPV;
• Manage interactions with French Health Authorities, including safety requests, regulatory reporting, and legal case coordination with Legal Affairs;
• Oversee and manage pharmacovigilance and medical information vendors, ensuring quality, compliance, and performance;
• Develop, maintain, and deliver PV training materials for internal teams and vendors, and supervise junior associates and trainees;
• Contribute to contractual and governance documentation, including joint operating procedures and PV clauses in commercial and non-commercial agreements;
• Handle medical information requests from healthcare professionals and patients, including validation of standard response letters;
• Ensure quality assurance and continuous improvement, including procedure writing, KPI monitoring, audit/inspection follow-up, reconciliation, and management of non-conformities.

Who You Are

You are a proactive and adaptable team player who enjoys working in collaborative, cross-functional environments. You naturally anticipate change and contribute to continuous improvement in Pharmacovigilance and Medical Information activities. You build strong, positive working relationships with internal stakeholders, vendors, and external partners, and you are comfortable operating in multicultural and international settings. Clear, professional, and thoughtful in your communication, you help support high-quality, compliant, and patient-focused outcomes.

Required Skills

• Pharm.D or MD with minimum 4 years of experience in Pharmacovigilance within the pharmaceutical or biotechnology industry;
• Strong ability to anticipate, detect, and evaluate medical risks, including safety signals and product quality complaints, with appropriate escalation;
• Proven experience in pharmacovigilance case management, including documentation, follow-up, data entry, and use of safety databases;
• Ability to read, analyze, and produce scientific documentation (reports, notes, standard letters) with a high level of accuracy;
• Excellent written and verbal scientific English communication skills;
• Strong analytical skills with the ability to interpret complex scientific and medical information and assess relevance;
• Demonstrated rigor, attention to detail, and compliance in information processing, archiving, and quality control in line with regulations and procedures;
• Ability to provide pharmacovigilance expertise within multidisciplinary and cross-functional teams;
• Strong organizational skills with the ability to prioritize workload and work independently, while contributing effectively to team objectives.