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Medical Director (SERM & Clinical Safety & Pharmacovigilance) – Remote – Brazil

Alphanumeric Systems

Novo Remote
Remote Senior 🇬🇧 English
MD or equivalent clinical development pharmacovigilance regulatory submissions

Descrição do cargo

About the role

Alphanumeric is hiring a Medical Director for a 1‑year remote contract to support a global pharmaceutical company's Safety Evaluation & Risk Management function. The role provides medical leadership for safety evaluation, benefit‑risk assessment, and risk management of products in clinical development and post‑marketing.

Key responsibilities

  • Lead safety evaluation and benefit‑risk assessments for assigned products.
  • Support pharmacovigilance and risk‑management activities across clinical development and marketed products.
  • Prepare and review scientifically sound responses to Health Authority Requests for Information (RFIs).
  • Analyze clinical and safety data to support regulatory and business decisions.
  • Participate in cross‑functional safety governance and product safety discussions.

Required profile

  • MD or equivalent physician qualification.
  • Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions.
  • Experience responding to Health Authority RFIs and supporting regulatory submissions.
  • Strong understanding of benefit‑risk assessment and safety evaluation.
  • Excellent scientific writing and communication skills; proficiency in English is mandatory.

Required skills

  • MD or equivalent medical qualification.
  • Experience in clinical development and pharmacovigilance.
  • Experience with regulatory interactions (FDA, EMA, PMDA, etc.).

What we offer

  • Salary base plus benefits.
  • Home office reimbursement.
  • Private health insurance.

Questions fréquentes

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Publicado há 2 dias

Expira em 1 mês

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Alphanumeric Systems