Tax Manager (Senior)

Darum lohnt es sich

ppElevate drug safety strategy and make a lasting impact across the product lifecycle. /p pProclinical is seeking a Tax Manager (Senior) to join a dynamic team in Switzerland.

You will play a key role in ensuring compliance with global health authority regulations and contribute to the development and implementation of safety strategies. /p pPlease note that to be considered for this role you must have the right to work in this location or hold an EU passport. /p h3Responsibilities /h3 ul liProvide strategic safety leadership across multiple programs or therapeutic areas. /li liOversee the safety profile of assigned products through pre- and post-marketing safety surveillance activities. /li liLead global safety strategy for program teams, ensuring data-driven review and assessment. /li liConduct safety signal detection and benefit-risk assessments for assigned products. /li liRepresent global safety in cross-functional meetings related to development projects and studies. /li liCollaborate with writers to develop and update aggregate safety reports and regulatory safety submissions. /li liWork closely with cross-functional teams, including Biostatistics, Clinical Translational Sciences, Research, and Regulatory Affairs, to develop risk management strategies. /li liProvide senior medical safety leadership in safety governance forums, such as Safety Review Committees and Data Monitoring Committees. /li liContribute to the development of safety-related sections in clinical protocols, Investigator's Brochures, informed consent forms, and other study-related documents. /li liSupport safety activities related to regulatory filings and responses to health authority queries. /li liEnsure consistency in safety data collection standards for clinical studies. /li liOversee the preparation and submission of high-quality safety reports. /li liConduct medical reviews of Serious Adverse Event reports to ensure timely regulatory submissions. /li liParticipate in regulatory inspections and internal audits. /li liContribute to safety process improvements and best practices across the organization. /li /ul h3Key Skills and Requirements /h3 ul liMedical degree (MD or MD-PhD). /li liStrong understanding of global pharmacovigilance principles and regulatory requirements. /li liExperience in signal detection, evaluation, and aggregate data analysis in clinical trials. /li liExcellent analytical and critical thinking skills for evaluating complex medical data. /li liStrong communication and collaboration skills for cross-functional teamwork. /li liAbility to prioritize effectively and deliver results within tight timelines. /li liFamiliarity with MedDRA coding and global PV regulations (e.g., CIOMS, EMA, FDA, ICH). /li /ul /p #J-18808-Ljbffr This role focuses on providing strategic safety leadership across multiple programs or therapeutic areas within the cardiovascular and pharmaceutical sectors.