Pharmacovigilance Doctor H/F - Excelya

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.About the Job

Join Excelya as a Médecin PV (Pharmacovigilance Physician), where our core values of Audacity, Care, and Energy guide our commitment to safety in drug development. In this crucial clinical role, you will be responsible for monitoring and ensuring the safety of pharmaceutical products, protecting patient health, and contributing to regulatory compliance.

This position offers an exciting opportunity to collaborate with a talented team dedicated to advancing pharmacovigilance practices in the ever-evolving landscape of clinical research.

Main Responsibilities:

- Provide PV and risk management to internal and external customers, Safety service for the assigned range of product under the supervision of Therapeutic head in charge.
- Provide inputs required cross to Safety Management Teams (SMTs) and GPV internal Safety Analysis Teams (SATs) Draft support documentation for the GBU TAH as required to external partners, and Health Authorities, and during internal and external negotiations
- Provide inputs to the safety management plan when required Support due diligence activities and pharmacovigilance agreements when required for the GBU products
- Provide support and insight for the preparation of clinical developments, protocols reviews Signal Detection and Assessment.
- Responsible for running signal detection and analysis process methodologies and interpretation analysis of the results for the range of products assigned with reporting to the TAH.
- Prepare aggregate safety data review activities and coordinate safety surveillance activities under the responsibility of the TAH.
- Provide proactive risk assessment, Co-lead benefit-risk assessment with other relevant functions Prepare the risk management strategies and plans and monitor effectiveness as directed by the GBUTAH / GBU Head and collaborate with Center of Excellence for Risk Management and Safety Epidemiology.
- Report Writing: Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products.

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique-

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe'sleading mid-size CROwith thebest employee experience. Ourone-stop provider service model-offering full-service, functional service provider, and consulting-enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with caremeans benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

About You

At Excelya, we seek passionate individuals who are ready to make impactful contributions in the realm of pharmacovigilance.

- Experience: Relevant clinical experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology industries.
- Skills: Strong understanding of drug safety regulations and reporting requirements. Excellent analytical and critical thinking skills with attention to detail.
- Education: Medical degree (MD or equivalent) with a focus on clinical pharmacology or related field.
- Languages: Fluency in French and English, both written and spoken, is essential.