Deskripsi Pekerjaan
Join the dynamic team at Tata Consultancy Services as a Safety Specialist in Pharmacovigilance. We are seeking a meticulous and detail-oriented professional to manage the lifecycle of pharmacovigilance case data. In this pivotal role, you will be responsible for the accurate entry, coding, and comprehensive review of safety information within our advanced PV systems. You will play a crucial role in ensuring data integrity, maintaining strict compliance with regulatory requirements, and supporting global patient safety initiatives. If you are passionate about healthcare, data management, and have a strong background in life sciences, this is an excellent opportunity to advance your career with a leading IT services provider.
Tanggung Jawab
- Manage and process pharmacovigilance case data, including initial intake and resolution.
- Enter detailed case information into PV systems with high accuracy and adherence to timelines.
- Code adverse events and medical terminology using standard dictionaries (e.g., MedDRA, WHO-ATC).
- Review case reports for completeness, consistency, and regulatory compliance.
- Ensure strict adherence to ICH-GCP guidelines and local regulatory standards.
- Communicate discrepancies to internal teams and support the investigation of missing data.
- Maintain and update PV databases to ensure up-to-date records.
Kualifikasi
- Bachelor’s degree in Pharmacy, Biology, Nursing, or a related Life Sciences field.
- Experience in Pharmacovigilance, Drug Safety, or Clinical Data Management.
- Strong knowledge of ICH guidelines (E2A, E2B, E2C) and regulatory frameworks.
- Proficiency in MS Office applications and PV software (experience with Argus or similar is a plus).
- Excellent attention to detail and strong analytical skills.
- Ability to work independently in a fast-paced, high-volume environment.
- Strong written and verbal communication skills in English.