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SERM Physician – Pharmacovigilance

Tata Consultancy Services · São Paulo

🇬🇧 English
Pharmacovigilance Risk Management Signal detection GVP modules CIOMS initiatives

Job description

About the role

Join one of the world’s largest IT services firms as a SERM Physician, contributing to safety evaluation and risk management for pharmaceutical products. You will work in a collaborative environment that values continuous learning and professional growth.

Key responsibilities

  • Conduct signal detection and evaluation for assigned products.
  • Prepare accurate evaluation documents for internal and regulatory safety data requests.
  • Assist in developing Risk Management Plans and Risk Tables.
  • Author regulatory periodic reports (PSUR, DSUR, PBRER) and related documentation globally.
  • Participate in process‑improvement initiatives within the Global Clinical Safety Platform.
  • Complete post‑audit/inspection activities within required timelines.
  • Support safety governance in clinical development and post‑marketing by establishing cross‑functional teams and implementing risk‑reduction strategies.

Required profile

  • Medical Doctor (physician) with relevant pharmacovigilance experience.
  • Fluent English communication skills.
  • Experience in safety evaluation, risk management, and regulatory reporting.
  • Knowledge of international pharmacovigilance requirements (ICH, GVP modules, CIOMS) and drug development processes.

Required skills

  • Pharmacovigilance
  • Risk Management
  • Regulatory reporting (PSUR, DSUR, PBRER)
  • Signal detection and evaluation
  • Knowledge of ICH, GVP, CIOMS guidelines

What we offer

  • Health, dental, and life insurance
  • Transportation and meal vouchers
  • Childcare assistance and gym membership
  • Psychological, legal, social, and financial support services
  • Professional development through certifications, online courses, and international experience
  • Performance recognition and referral bonuses

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Published 3 months ago

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Tata Consultancy Services

São Paulo