Opportunité de Carrière en République Tchèque : Senior Specialist en Réglementation et Pharmacovigilance

PrimeVigilance : Un Leader en Pharmacovigilance

PrimeVigilance, membre d’Ergomed Group, est un fournisseur de services spécialisé en pharmacovigilance établi en 2008. Avec une croissance organique continue et un personnel réparti à travers l’Europe, l’Amérique du Nord et l’Asie, PrimeVigilance se positionne comme un leader mondial dans le domaine, offrant des services en Informations Médicales, Pharmacovigilance, Affaires Réglementaires et Assurance Qualité. L’entreprise s’engage à maintenir des relations durables avec ses partenaires du secteur pharmaceutique et biotechnologique, couvrant tous les domaines thérapeutiques, y compris les dispositifs médicaux.

Description du Poste

Le Senior Specialist, Regulatory and Pharmacovigilance joue un rôle clé dans le développement de stratégies basées sur les exigences réglementaires. Ce poste requiert la coordination et la gestion efficaces des livrables réglementaires au sein d’une structure bien organisée :

• Contact Local en Pharmacovigilance : Agir en tant que personne de contact locale pour la pharmacovigilance dans le pays désigné.
• Leadership : Diriger des projets de complexité moyenne à élevée, en veillant à ce que l’équipe respecte les objectifs convenus.
• Stratégie : Élaborer des stratégies et gérer les activités de configuration en collaboration avec des membres seniors de l’équipe.
• Gestion des Risques : Identifier et aborder rapidement les risques potentiels en mettant en œuvre des mesures préventives.
• Suivi et Formation : Assurer la conformité des membres de l’équipe et fournir un soutien dans le développement de propositions et de budgets.

Qualifications Requises

Les candidats doivent posséder des qualifications spécifiques qui renforcent leur aptitude à occuper ce poste :

• Diplôme : Licence en Chimie, Sciences de la Vie, Soins Infirmiers ou expérience équivalente.
• Expérience : Solide expérience dans l’industrie pharmaceutique, les organismes de réglementation ou les CRO.
• Compétences Linguistiques : Maîtrise de l’anglais et de la langue officielle du pays d’affectation. La connaissance de l’allemand, du français ou de l’italien est un atout.
• Compétences Organisationnelles : Excellentes capacités de planification et d’organisation.

Avantages de Travailler chez PrimeVigilance

PrimeVigilance place un fort accent sur la diversité, l’équité et l’inclusion. L’entreprise propose un environnement de travail humain et équitable, favorisant le développement personnel et professionnel de chacun :

• Développement Careers : Opportunités de formation et de développement de carrière internes.
• Environnement Collaboratif : Cultiver des relations professionnelles avec des collègues du monde entier, avec l’anglais comme langue d’entreprise.

Engagement Éthique d’Artia13

L’annonce exposée répond aux standards d’Artia13, mettant en avant des valeurs de transparence et d’égalité des chances. Il est essentiel que les entreprises s’engagent à offrir un environnement inclusif et non discriminatoire, en assurant une gestion transparente des candidatures.

Les candidats intéressés par ce poste peuvent postuler via le lien suivant : Postulez dès maintenant !

Engageons-nous ensemble pour un avenir où la régulation pharmaceutique et la pharmacovigilance contribuent à améliorer la vie des patients.

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📅 Date de publication de l’offre : Thu, 29 May 2025 22:10:03 GMT

🏢 Entreprise : PrimeVigilance

📍 Lieu : Praha

💼 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

➡️ Candidater en ligne

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