Drug Safety and Pharmacovigilance Specialist at Santhera Pharmaceuticals
Santhera Pharmaceuticals (Schweiz) AG
Date de publication :
18 février 2025Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Pratteln
Résumé de l'emploi
Santhera Pharmaceuticals, entreprise suisse, se consacre aux maladies neuromusculaires. Rejoignez-nous pour améliorer la vie des patients atteints de maladies rares.
Tâches
- Diriger le système de pharmacovigilance mondial de Santhera.
- Assurer la conformité réglementaire pour les essais cliniques.
- Fournir des rapports de sécurité de haute qualité aux autorités.
Compétences
- Diplôme médical ou scientifique avec 10 ans d'expérience en sécurité des médicaments.
- Compétences en leadership pour représenter DS&PV.
- Capacité à travailler de manière autonome en équipe.
Résumé de l'annonce originale
Est-ce utile ?
Head Drug Safety and Pharmacovigilance (DS&PV) Location: Pratteln, Switzerland (Hybrid) Scope of Work
We are looking for an experienced and strategic leader to join our team as Head of DS&PV. In this role, you will oversee Santhera's global PV systems, ensuring compliance with all PV and Quality obligations as a marketing authorization holder and clinical trial sponsor. You will maintain an overview of the safety profiles for all authorized and clinical-stage products. You will also provide guidance on drug safety in development programs, including input on IBs, IMPDs, protocols, and the company's core safety information data sheet. Additionally, you will ensure adequate support and resources from the CEO and General Managers. This role reports to the Chief Medical Officer. Key Responsibilities
- Oversee Santhera's global Pharmacovigilance (PV) system, ensuring compliance with regulations and managing PV vendors and activities.
- Ensure Santhera meets its obligations as a clinical trial sponsor and marketing authorization holder, maintaining a robust PV framework.
- Monitor drug safety across all products, ensuring timely identification, escalation, and management of safety concerns.
- Oversee the execution of QPPV responsibilities, ensuring compliance with EU and global regulatory requirements, including validation oversight.
- Supervise risk management systems, the implementation of risk minimization measures, and the oversight of
- Ensure high-quality safety reporting, including PSURs, Risk Management Plans, and timely submissions to health authorities.
- Maintain oversight of company core safety information (CCSI), ensuring it reflects current scientific knowledge and regulatory recommendations.
- Collaborate with regulatory teams to address safety-related regulatory actions and respond promptly to health authority requests.
- Medical, Scientific or equivalent Degree
- At least 10 years of experience in all aspects of drug safety and pharmacovigilance (clinical development and post marketing)
- Expert knowledge of European and US Drug Safety and Pharmacovigilance requirements and strong knowledge in other geographical areas
- Expert knowledge of Drug Safety/Pharmacovigilance practices and tools (e.g. Argus Database)
- Strong leadership skills to represent DS&PV at the company level and communicate key issues and opportunities effectively.
- Agile and flexible mindset to set priorities and work efficiently within a small company.
- Excellent planning, organization, and time management skills to meet tight deadlines in a fast-paced environment.
- Strong verbal and written English communication skills, with attention to detail and a quality-oriented approach.
- Ability to work independently while being a reliable team player, managing multiple projects in a matrix environment.
