Senior Specialist, Regulatory and Pharmacovigilance
Opportunité Professionnelle : Senior Specialist, Regulatory and Pharmacovigilance
Présentation de l’Entreprise
PrimeVigilance, faisant partie du groupe Ergomed, est un fournisseur de services de pharmacovigilance reconnu à l’échelle mondiale. Créée en 2008, la société a connu une croissance organique constante, avec des employés répartis à travers l’Europe, l’Amérique du Nord et l’Asie. PrimeVigilance offre des services variés dans les domaines de :
- Information Médicale
- Pharmacovigilance
- Affaires Réglementaires
- Assurance Qualité
Avec une attention particulière à la formation et au développement des compétences, PrimeVigilance met en avant l’importance de l’expérience employé et de l’équilibre entre vie professionnelle et personnelle. L’entreprise s’engage à bâtir des relations durables avec ses partenaires, contribuant ainsi significativement à l’amélioration de la vie des patients.
Description du Poste
Le poste de Senior Specialist, Regulatory and Pharmacovigilance (PV) revêt une grande responsabilité. Le professionnel sera chargé de développer des stratégies conformes aux exigences réglementaires tout en veillant à la livraison des objectifs établis dans le plan de pharmacovigilance. Ce rôle inclut la liaison entre les secteurs réglementaires et d’autres fonctions clés, comme les partenaires externes et les autorités.
Responsabilités Clés
- Jouer le rôle de *Local Contact Person* pour la pharmacovigilance dans le pays désigné.
- Assurer la direction et la représentation fonctionnelle pour des projets de complexité moyenne à élevée, garantissant la coordination efficace des livrables réglementaires.
- Développer des stratégies en collaboration avec des membres senior de l’équipe.
- Identifier et atténuer les risques potentiels tout en fournissant des solutions pour des problèmes de performance.
- Gérer la collecte et la révision des CVs et autres documents nécessaires des contacts locaux en pharmacovigilance.
- Former et mentoriser les membres junior de l’équipe.
- Rester informé des changements législatifs et veiller à la mise à jour des bases de données sur la réglementation.
Qualifications Requises
- Baccalauréat en Chimie, Sciences de la Vie ou expérience équivalente.
- Expérience significative dans l’industrie pharmaceutique ou les organismes de réglementation.
- Solide connaissance des réglementations ICH GCP et GVP.
- La maîtrise de l’anglais est indispensable, tant à l’écrit qu’à l’oral.
- Compétences en planification et en organisation, avec une attention particulière aux détails.
Environnement de Travail
PrimeVigilance valorise la diversité, l’équité et l’inclusion, s’efforçant de créer un milieu de travail où chacun peut s’épanouir. L’entreprise offre des opportunités de formation et de développement de carrière, favorisant un environnement amical et coopératif.
Valeurs Fondamentales de PrimeVigilance :
- *Qualité*
- *Intégrité et Confiance*
- *Passion et Motivation*
- *Agilité et Réactivité*
- *Appartenance*
- *Partenariats Collaboratifs*
Postulez dès Maintenant
Pour ceux qui souhaitent rejoindre une entreprise à l’avant-garde de la pharmacovigilance et faire une différence dans la vie des patients, nous vous encourageons à postuler ici.
Informations Complémentaires
- Localisation : Barcelone
- Date de Publication : Samedi, 24 Mai 2025
- Salaire Attendu : Non spécifié
PrimeVigilance aspire à recevoir des candidatures de professionnels expérimentés qui partagent leurs valeurs pour construire ensemble un avenir meilleur dans le domaine de la santé.
📅 Date de publication de l’offre : Sat, 24 May 2025 22:36:03 GMT
🏢 Entreprise : PrimeVigilance
📍 Lieu : Barcelona
💼 Intitulé du poste : Senior Specialist, Regulatory and Pharmacovigilance
💶 Rémunération proposée :
📝 Description du poste : Company DescriptionPrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.Come and join us in this exciting journey to make a positive impact in patient’s lives.Job DescriptionThe Senior Specialist, Regulatory and PV Network is responsible for developing the strategy based on regulatory requirements and for driving regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies.The Senior Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country.Job Responsibilities
- Act as Local Contact Person for Pharmacovigilance for the designated country
- Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates
- With the help of a senior member of the team, develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents)
- Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures
- Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
- Collect, review, track and maintain LCPs’ CVs, job descriptions, training records, contact details and monthly reports
- Ensure correct training assignment to and training compliance by the LCPs
- Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS
- Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
- Prepare client’s invoices and review/approve vendors’ project invoices
- Provide training, coaching and mentoring to junior members of staff
- Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
- Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
- Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required
- Track LCPs’ key performance indicators and prepare monthly summary reports
- Provide feedback on performance of vendors to aid their assessment
- Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.
Qualifications
- Bachelor’s Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
- Strong experience within pharmaceutical or CRO industry or Regulatory body
- Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency
- PV training and/or working experience and other educational or professional background as required locally
- Fluent in English, both written and verbal
- Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance
- Proficiency in German, French, or Italian is a plus but not mandatory
- Good planning and organizational skills
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Good attention to detail
Additional InformationWhy PrimeVigilanceWe prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.We offer:
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.#LI remote
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