22 sep
|
Tata Consultancy Services
|
Ciudad de México
22 sep
Tata Consultancy Services
Ciudad de México
TCS is seeking a Medical Reviewer to support the medical review and assessment of adverse event reports, ensuring the accuracy, quality, and regulatory compliance of pharmacovigilance and drug safety activities.
The Medical Reviewer will collaborate with Drug Safety teams, pharmacovigilance professionals, and cross-functional stakeholders to review individual case safety reports, provide medical expertise, support regulatory compliance, and ensure the effective evaluation of safety information throughout the product lifecycle.
Key Responsibilities
- Perform medical review and assessment of adverse event and drug safety cases.
- Evaluate case narratives, laboratory data, medical history, concomitant medications, and suspect products.
- Assess medical causality, seriousness, and labeling relevance of safety cases.
- Review and respond to queries related to individual case safety reports.
- Generate and track medically relevant follow-up requests for additional safety information.
- Support Drug Safety teams with medical expertise and product-related knowledge.
- Ensure compliance with regulatory requirements, SOPs, and pharmacovigilance processes.
- Participate in audits, safety reviews, and stakeholder discussions.
Skills & Qualifications
Required
- Bachelor of Medicine and Bachelor of Surgery (MBBS) or equivalent medical degree.
- 9 months to 4 years of experience in Pharmacovigilance, Drug Safety, Clinical Research, or related fields.
- Strong communication skills in English.
- Availability for full-time employment.
- Computer literacy, including Microsoft Office applications.
Preferred
- Experience reviewing Individual Case Safety Reports (ICSRs).
- Knowledge of general regulatory and drug safety requirements.
Location
Mexico City
Work Model
On-site
Benefits:
- Major Medical Insurance.
- Dental Insurance.
- Life Insurance.
- Grocery Vouchers.
- Christmas Bonus.
- Vacation days according to Mexican labor law.
- Profit Sharing (PTU).
Other Considerations:
Tata Consultancy Services is an equal opportunity employer. Our commitment to diversity and inclusion drives us to provide equal opportunities to all candidates who meet our required knowledge and competency needs—regardless of socio-economic background, race, color, national origin, religion, sex, gender identity, age, marital status, disability, sexual orientation, or any other characteristic.
📌 Medical Reviewer (Ciudad de México)
🏢 Tata Consultancy Services
📍 Ciudad de México