Senior Pharmacovigilance Officer (Medical Device) F/H

BTG Specialty Pharmaceuticals; Paris; Hybride; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading specialty pharmaceutical company in Paris is looking for a Senior Pharmacovigilance / Medical Device Vigilance Officer to ensure compliance in pharmacovigilance activities. The ideal candidate will have a scientific background, at least 5 years of experience in pharmacovigilance, and proficiency in medical English. The role allows for remote work two days a week, promoting a balanced work culture with competitive compensation and benefits.

Prestations

Competitive compensation

Remote work options

10 RTT days per year

Qualifications

• Minimum 5 years experience in pharmacovigilance.
• Expertise in regulations such as MDR and MDSAP.

Responsabilités

• Serve as main contact during internal audits and inspections.
• Ensure compliance with vigilance requirements.
• Manage safety email inbox and draft risk management plans.

Connaissances

Proficiency in medical English

Strong IT skills

Knowledge of GVP EU/UK/US

Ability to manage variable workloads

Formation

Scientific background with knowledge of medical devices

Description du poste

Come and Save Lives with Us!

SERB is a fast-growing specialty pharmaceutical company that provides healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies.

For over 30 years, we have consistently supplied emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes.

Today, SERB employs over 500 people across 18 countries, with group revenue exceeding €400 million. We have a strong presence in the US, Europe, and the Middle East, and a global network of trusted distribution partners, making essential medicines available in over 100 countries.

Our purpose is supported by our four key values:

• We prioritize patients
• We act with integrity and accountability
• We work together as one team
• We seek better ways forward

Through targeted acquisitions and new market entries, we aim to improve the standard of care for more patients worldwide.

Mission générale

The Senior Pharmacovigilance / Medical Device Vigilance Officer supports the Pharmacovigilance / Medical Device Vigilance / Medical Department daily and ensures compliance with these activities.

Responsibilities include, but are not limited to:

Expert in Medical Devices

• Main contact during internal audits and inspections by notified bodies
• Updating controlled documents related to MDR/MDSAP regulations
• Ensuring compliance with vigilance requirements (timely submission of individual and aggregate reports)
• Monitoring regulatory intelligence, conducting gap analyses, and updating procedures
• Managing data exchange agreements (SDEA): regular updates, model improvements, regulatory compliance
• Collaborating across departments for projects and audit preparations
• Participating in signal management: identification and evaluation from all sources

Senior PV Officer

• Managing global and local scientific literature (rotation)
• Supervising signal detection processes
• Drafting and reviewing signal detection reports
• Drafting and reviewing periodic safety reports (PBRER, PSUR, PADER, ASR)
• Creating and updating quality documents
• Responding to health authority requests (RFI/RSI)
• Drafting risk management plans and assessing risk minimization measures
• Conducting ad hoc bibliographic research (development projects, PSUR, authority requests, RMP, signal detection, Level 2 medical information, off-label use, animal origin for medical devices)
• Managing safety email inbox (rotation)

Qualifications for success:

Technical skills

• Proficiency in medical English (reading, writing, interpretation, translation)
• Strong IT skills
• Ability to manage variable workloads
• Knowledge of GVP EU/UK/US, MDR, MDSAP

General skills

• Rigor
• Autonomy
• Good interdepartmental relations
• Team spirit

Education and Experience

• Scientific background with knowledge of medical devices environment
• Minimum 5 years experience in pharmacovigilance

Contract

Permanent position (CDI)

Offices in Paris 8th, near Line 1 and RER A stations

Remote work possible 2 days a week, 10 RTT days per year

SERB Pharmaceuticals is an equal opportunity employer. We offer competitive compensation and benefits, stimulating opportunities, and a work culture based on strong values.