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This job expired on 11/08/2026. It no longer accepts applications.
SERM Physician – Pharmacovigilance
Tata Consultancy Services · São Paulo
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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Tata Consultancy Services
São Paulo
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