Auf einen Blick
- Aufgaben: Leite die Sicherheitsstrategie für innovative Arzneimittel und sorge für globale Compliance.
- Unternehmen: Proclinical, ein dynamisches Unternehmen im Gesundheitssektor in der Schweiz.
- Vorteile: Wettbewerbsfähiges Gehalt, flexible Arbeitszeiten und Entwicklungsmöglichkeiten.
- Weitere Informationen: Arbeiten in einem kreativen Team mit exzellenten Karrierechancen.
- Warum dieser Job: Gestalte die Zukunft der Arzneimittelsicherheit und mache einen echten Unterschied.
- Qualifikationen: Medizinische Ausbildung (MD oder MD-PhD) und Erfahrung in der Pharmakovigilanz.
Das prognostizierte Gehalt liegt zwischen 80000 - 110000 € pro Jahr.
Elevate drug safety strategy and make a lasting impact across the product lifecycle.
Proclinical is seeking a Tax Manager (Senior) to join a dynamic team in Switzerland.
This role focuses on providing strategic safety leadership across multiple programs or therapeutic areas within the cardiovascular and pharmaceutical sectors.
You will play a key role in ensuring compliance with global health authority regulations and contribute to the development and implementation of safety strategies.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities Provide strategic safety leadership across multiple programs or therapeutic areas.
Oversee the safety profile of assigned products through pre- and post-marketing safety surveillance activities.
Lead global safety strategy for program teams, ensuring data-driven review and assessment.
Conduct safety signal detection and benefit-risk assessments for assigned products.
Represent global safety in cross-functional meetings related to development projects and studies.
Collaborate with writers to develop and update aggregate safety reports and regulatory safety submissions.
Work closely with cross-functional teams, including Biostatistics, Clinical Translational Sciences, Research, and Regulatory Affairs, to develop risk management strategies.
Provide senior medical safety leadership in safety governance forums, such as Safety Review Committees and Data Monitoring Committees.
Contribute to the development of safety-related sections in clinical protocols, Investigator's Brochures, informed consent forms, and other study-related documents.
Support safety activities related to regulatory filings and responses to health authority queries.
Ensure consistency in safety data collection standards for clinical studies.
Oversee the preparation and submission of high-quality safety reports.
Conduct medical reviews of Serious Adverse Event reports to ensure timely regulatory submissions.
Participate in regulatory inspections and internal audits.
Contribute to safety process improvements and best practices across the organization.
Key Skills and Requirements Medical degree (MD or MD-Ph D).
Strong understanding of global pharmacovigilance principles and regulatory requirements.
Experience in signal detection, evaluation, and aggregate data analysis in clinical trials.
Excellent analytical and critical thinking skills for evaluating complex medical data.
Strong communication and collaboration skills for cross-functional teamwork.
Ability to prioritize effectively and deliver results within tight timelines.
Familiarity with Med DRA coding and global PV regulations (e. g., CIOMS, EMA, FDA, ICH). #J-18808-Ljbffr
