Tata Consultancy Services (TCS) is a software services consulting company headquartered in Mumbai, India. TCS is the largest provider of information and business process outsourcing services in Asia. TCS is a flagship subsidiary of one of India's largest and oldest conglomerate company, the Tata Group, which has interests in areas such as energy, telecommunications, financial services, manufacturing, chemicals, engineering, materials, government and healthcare.

Post : Pharmacovigilence Executive

Roles and Responsibilities:
• Ensure completion of basic training in case handling. Begin and complete the process for competency sign off for A category cases. Ensure that the case is QREd before closure in case the administrator is not signed off for A category cases.
• Enter initial and follow-up information for individual adverse event case reports of low business risk onto the global Patient Safety database, using data interpretation, coding and writing skills in accordance with the current Data Entry Process Instructions and associated SOPs and OPI to ensure consistency of case entry and high data quality standards.
• Select the cases from the relevant mailbox (Clinical trial, Post Marketed) and enter the Patient Safety Administrator person’s name in relevant field in mailbox tracker.
• Begin to enter the case in Sapphire completing Log pages 1 and 2, save the information to generate case ID.
• Assign the case to a case owner as per Global Case Handling SOP.
• Continue entering the case - if the Patient Safety Administrator has been signed off on category A cases – if it is required.
• Ensure compliance with global and local procedural documents and local implementation of AZ and TCS policies, processes and procedures.
• Perform all activities within the required timeframes to ensure regulatory compliance.
• Support a performance-driven culture.
• The case handler could move on to B cases if the team leader assess them to be ready after A sign off.
Note: There is no B category in the Clinical Trial Process.
• All new recruits will initially perform the responsibilities as a Patient Safety Administrator.
• Patient Safety Administrator can also act as a Mailbox Handler, Mailbox Handler Back up, License Partner Case Reporting personnel or Trainer, and also can work as a Literature Case Handler.
• If the additional task(s) requires specific training/hands-on-training it has to be completed before taking over it.

Additional Information:
Experience: 1-4 Years
Location: Mumbai
Education: B.Pharm
Job Id : 130583
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Pharmacovigilance