Helping Clients Create the Future TCS combines tech expertise and business intelligence to catalyze change and deliver results. Our mission is to help customers achieve their business objectives by providing innovative, best-in-class consulting, IT solutions and services and to make it a joy for all stakeholders to work with us.
TCS is hiring
Pharmacovigilance
Job Id : 343594
Experience Range – 2 to 6 Years
Educational Qualification(s) Required – BPharm, BSc, MPharm, MSc, BAMS & BDS.
Job Description:
• Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code and enter data.
• Be fully competent to perform all steps within the case-handling processing.
• Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures.
• Responsible for follow up procedures.
• Contribute to the development and implementation of new safety-related systems, processes, and procedures within the process.
• Support a performance-driven culture.
• Excellent communication skills (verbal and written)
Validation Associate
Job Id : 341103
Job Location – Mumbai, Pune, Bangalore, Indore, Ahmedabad
Experience Range – 2 to 10 Years
Educational Qualification(s) Required – Graduate/Postgraduate (Any life-science/ Engineering)
Responsibilities
• Looking for Validation (Quality control) associates with 9 months to 5 years of experience in eDC or non eDC edit checks validation & script creation in any eDC systems like InFomr, Veeva, Rave..etc
1. Data validation test script creation:
• Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification(DVS). Document expected results for each testing scenario.
• Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation.
2. Data validation test script execution:
• Entry of test data as specified in each testing scenario
• Compare the result obtained through entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failure.
• Document validation failures.
• For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenario.
CDR - Clinical Data Reviewer (Clinical Data Management)
Job Id : 342180
Job Location – Mumbai, Pune, Bangalore, Indore, Ahmedabad
Experience Range – Min 2 to 5 Years of relevant experience into CDM
Educational Qualification(s) Required – B. Pharma, M. Pharma, Pharma -D, BDS
Communication – Good Communication
CDR - Clinical Data Reviewer
• CDR 2 – 5 Year of Core Clinical Data Management Experience
• Work independently and accountable for study Data Management deliverables.
• Coordinate with Biostatistician, Clinical, Medical and local study team as applicable.
• Represent Data Management team at study team and cross functional study team.
• Worked on all phases of Clinical Data Management – Set up, conduct and close out.
• Minimum 1 years of experience of leading a clinical trial.
• Provide training/mentoring to team members.
• To work on any study specific activities assigned by Line Managers
• Draft Study timelines and must ensure all stakeholders adhere to it and escalate it whenever needed.
SDM - Study Data Manager
Job Id : 341097
Experience Range – Min 2 to 10 Years of relevant experience into LDM
Educational Qualification(s) Required – B. Pharma, M.Pharma, Pharma -D, BDS
Communication – Good Communication
Study Data Manager (SDM)
1. Work independently and accountable for study Data Management deliverables
2. Coordinate with Biostatistician, Clinical, Medical and local study team as applicable
3. Represent Data Management team at study team and cross functional study team
4. Worked on all phases of Clinical Data Management – Set up, conduct and close out
5. Minimum 1 yrs of experience of leading a clinical trial
6. Provide training/mentoring to team members
7. To work on any study specific activities assigned by Line Managers
8. Draft Study timelines and must ensure all stakeholders adhere to it and escalate it whenever needed
Clinical SAS Programmer
Job Id : 341305
Experience: 4 - 7 years’ relevant experience in Clinical SAS Programming
Qualification : Any Life Science graduate
Skills Required:
• Hands on Experience minimum 4 to 5 years on SAS/SQL programming
• Experienced from Life Science or Clinical Domain only.
• Having knowledge in SQL programming with clear understanding of Joins, Unions.
• Having good experience in generating Reports, Listings, Reconciliations reports, Manual Data Review checks in SAS.
• Experience in SDTM, ADAM, TFL will be an added advantage.
Skill Details :
•Pharmacovigilance : 2+ years of experience in Drug Safety, Case Processing, ICSR, ARGUS or ARISG.
•eDC Programmer : Experience in eCRF build and edit checks build in Veeva studio.
•Validation Associate : Script creation in Inform, Veeva, Rave, etc.
•Clinical
Data Reviewer : External vendor data reconciliations, SAE
reconciliations. Experience on Veeva CDMS or Medidata / InForm.
•Study Data Manager : Experience in leading Set-Up, Conduct and Close-Out studies.
•SDTM Programmer : Experience in SDTM Programming and SAS Programming.
Documents to carry :
• Updated copy of TCS Application form with Resume
• Original & photocopy of Government ID proof (Aadhar Card / Pan Card / Passport / Voter’s ID)
• 1 Passport size photo
• Degree certificate or provisional certificate
• SSC, HSC & all semester’s marksheet
Interested candidates can directly visit TCS Mumbai - Olympus A, Hiranandani Estate to appear for the interview.
Walk-In Date : Saturday 4th January 2025
Time : 10 AM to 3 PM
Contact Person : Nidhi Nigam
Location : Tata Consultancy Services Limited, TCS Olympus A , Regent St, Hiranandani Estate - Thane West, Thane - 400607
Pharmacovgilance : Click here
Validation Associate : Click here
Clinical Data Reviewer : Click here
Study Data Manager : Click here
SDTM Programmer : Click here
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