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Senior Tax Manager – Strategic Safety Leadership

Proclinical Staffing · Zurich

Senior 🇬🇧 English
MedDRA coding signal detection aggregate data analysis

Job description

About the role

Proclinical is looking for a Senior Tax Manager to provide strategic safety leadership across multiple cardiovascular and pharmaceutical programs in Switzerland. You will ensure compliance with global health authority regulations and drive the development and implementation of safety strategies throughout the product lifecycle.

Key responsibilities

  • Lead safety strategy for multiple programs, overseeing pre‑ and post‑marketing surveillance.
  • Conduct safety signal detection, benefit‑risk assessments, and aggregate data analysis.
  • Represent global safety in cross‑functional meetings and safety governance forums.
  • Collaborate with Biostatistics, Clinical Translational Sciences, Research, and Regulatory Affairs to develop risk‑management plans.
  • Prepare and submit high‑quality safety reports and regulatory safety submissions.
  • Review Serious Adverse Event reports and support regulatory inspections and audits.
  • Contribute to safety sections of clinical protocols, Investigator’s Brochures, and informed consent forms.

Required profile

  • Medical degree (MD or MD‑PhD) with strong understanding of global pharmacovigilance principles.
  • Proven experience in signal detection, evaluation, and aggregate data analysis in clinical trials.
  • Excellent analytical, critical‑thinking, and communication skills.
  • Ability to prioritize tasks and deliver results within tight timelines.

Required skills

  • MedDRA coding
  • Familiarity with CIOMS, EMA, FDA, and ICH regulations
  • Signal detection techniques
  • Aggregate data analysis

Questions fréquentes

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Published 3 months ago

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Proclinical Staffing

Zurich