Pharmacovigilance Regulatory Compliance Unit Officer
il y a 2 jours
**About the Job**
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
**Main Responsibilities**:
- Manage non-conformities and related CAPAs (Corrective and Preventive Actions), including:
- Deviations related to late submissions of ICSRs to Health Authorities/Partners
- Delayed submission of periodic safety reports or any regulatory deliverables
- Procedural non-compliance and review of deviations opened by Local Safety Officers
- Coordinate the update and maintenance of the annual revision plan for quality documents managed by Global Safety
- Draft and maintain quality documents within scope, ensuring alignment with current regulatory requirements
- Generate, analyze, and share compliance performance indicators for the pharmacovigilance (PV) and PV quality systems
- Conduct qualification assessments of commercial partners and vendors involved in PV activities, ensuring proper documentation
- Coordinate responses to partner and regulatory risk analysis questionnaires
- Lead the coordination of audits and regulatory inspections by:
- Organizing the agenda and logistics
- Gathering required documentation
- Liaising with key stakeholders
- Managing and tracking audit/inspection observations and responses
- Ensuring audit documentation is properly archived in the designated system
**Requirements**:
**About You**:
At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.
- Experience: Proven ability to thrive in collaborative, fast-moving environments (talent matters most to us)
- Skills: Solid understanding of global PV regulations and quality systems, experience in managing CAPAs, deviations, and regulatory compliance indicators, familiar with the preparation and conduct of audits and inspections (internal and external).
- Education: Doctor of Pharmacy (PharmD) degree required.
- Languages: Fluent in written and spoken English and French; strong communication skills with global teams.
**Benefits**
**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’s leading mid-size CRO with the best employee experience. Our one-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 care means 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.
-
Pharmacovigilance Officer
il y a 4 jours
Boulogne-Billancourt, France Excelya Temps pleinHybridOperations, PV & SafetyFull time Boulogne-Billancourt, Île-de-France, France OVERVIEW Description About the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an...
-
Vigilances Et Medical Information Compliance Lead
il y a 4 jours
Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps pleinIPSEN est un groupe biopharmaceutique mondial, axé sur l’innovation et l’amélioration des soins aux patients. Rejoindre IPSEN, c’est intégrer une organisation dynamique, engagée et tournée vers l’excellence. En tant que **Vigilance et Medical Information Compliance Lead**, vous serez responsable de garantir la conformité des activités de...
-
Apprentissage Assistant(E) Pharmacovigilance
il y a 5 jours
Boulogne-Billancourt, France A+A Temps plein**Description de l'entreprise**: APLUSA est un des leaders mondiaux des études de marché dans le domaine de la santé. Responsables vis-à-vis de nos écosystèmes et socio systèmes, nous réalisons cette mission en offrant à nos 160+ collaborateurs internationaux la possibilité de s’épanouir dans un travail utile et valorisant. Devenez Aplusien...
-
Apprentissage Assistant(E) Pharmacovigilance
il y a 5 jours
Boulogne-Billancourt, France AplusA Temps pleinAPLUSA est un des leaders mondiaux des études de marché dans le domaine de la santé. Responsables vis-à-vis de nos écosystèmes et socio systèmes, nous réalisons cette mission en offrant à nos 160+ collaborateurs internationaux la possibilité de s’épanouir dans un travail utile et valorisant. Devenez Aplusien ! **Poste**: Sous la supervision de...
-
Regulatory Affairs Specialist
il y a 4 jours
Boulogne-Billancourt, France Excelya Temps pleinHybridOperations, PV & SafetyFull time Boulogne-Billancourt, Île-de-France, France OVERVIEW Description About the Job Join Excelya as a Regulatory Officer & Promotional Information, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and...
-
Regulatory Affairs Specialist
il y a 2 jours
Boulogne-Billancourt, France Excelya Temps plein**About the Job** Join Excelya as a **Regulatory Officer** **& Promotional Information**, where **Audacity, Care, and Energy** define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a...
-
Senior Manager, Cmc Regulatory Strategy
il y a 2 jours
Boulogne-Billancourt, France Ipsen Innovation (SAS) Temps plein**Job Title**:Senior Manager, CMC Regulatory Strategy - ** Division / Function**: Global Regulatory Affairs (GRA) - Prepare throughout the different phases of development CMC regulatory strategy roadmaps for assigned projects aligned with pre-clinical, clinical and LCM programs. - Collaborate closely with Pharmaceutical Development, and Technical Operations...
-
Apprentice - Global Regulatory Operations (H/F)
il y a 5 jours
Boulogne-Billancourt, France Ipsen Innovation (SAS) Temps pleinSpecializes in defining and implementing policies and processes to ensure products meet regulatory standards and compliance certifications. Participates in product design reviews, identifies and interprets applicable regulatory standards from the initial product design throughout production and commercialization. **Main tasks** - Collaborate with the...
-
Assistant(E) Administratif(Ve) Pharmacovigilance
il y a 12 heures
Boulogne-Billancourt, France A+A Temps plein**Description de l'entreprise**: - A_PLUS_A _est un des leaders mondiaux des études de marché dans le domaine de la santé. Responsables vis-à-vis de nos écosystèmes et socio systèmes, nous réalisons cette mission en offrant à nos 160+ collaborateurs internationaux la possibilité de s’épanouir dans un travail utile et valorisant. Devenez...
-
Compliance Officer Expert
il y a 2 semaines
Boulogne-Billancourt, France BNP Paribas Temps plein**Leader européen de services immobiliers, BNP Paribas Real Estate couvre l’ensemble du cycle de vie d’un bien : Promotion, Transaction, Conseil, Expertise, Property Management et Investment Management.** **Avec 5 000 collaborateurs, BNP Paribas Real Estate accompagne localement propriétaires, locataires, investisseurs et collectivités dans 30 pays...
