Medical Review
4 semanas atrás
Come to one of the biggest IT services companies in the world Here you can transform your career Why join TCS? At TCS, we believe that people make the difference. We foster a culture of unlimited learning, full of opportunities for improvement and mutual development. It's an ideal environment to expand ideas using the right tools, contributing to our success in a collaborative setting. We are looking for a Medical Review Specialist who wants to learn and advance their career. Responsibilities include: Providing causality assessments in safety databases (e.g., Argus) for various case types including clinical trials, spontaneous reports, post-marketing studies, legal cases, and literature cases. Reviewing case reports for medical accuracy, including validation of adverse events. Requesting follow-up information to ensure cases have sufficient data for robust causality assessment. Evaluating and interpreting clinical data, and discussing findings internally and externally. Qualifications: Graduated in Medicine. Fluent in English. Understanding of Drug Safety and Regulatory processes. Knowledge of pharmacovigilance practices, clinical development, and ICH/GCP principles. Good problem-solving and decision-making skills. Proficiency in MS Office. Excellent communication skills, both written and verbal. Knowledge of US and EU pharmacovigilance regulations is a plus. Additional information: Please attach your resume in English. What we offer: Health and life insurance. Gympass and wellness programs. Psychological, legal, social, and financial support through TCS Cares. Partnerships with educational institutions and reimbursement for certifications. Access to TCS Learning Portal with online courses and live training. International experience opportunities. Referral bonuses and recognition programs. An inclusive culture committed to diversity and equal opportunity. Additional details: Seniority level: Mid-Senior level. Employment type: Full-time. Job function: Information Technology and Research. Industry: Pharmaceutical Manufacturing. #J-18808-Ljbffr
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