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.
Post : Study Data Manager, Pharmacovigilance, Clinical Operations
Study Data Manager -Mumbai
Job Description
• Responsible & Accountable for the assigned study conduct activities, in clinical trials from TCS.
• Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
• Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies.
• To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory).
• SPOC for the study communications from TCS
• Proactively highlight any risks associated with the study along with the mitigation plan.
• Establish a partnership with the stakeholders at operational level to work seamlessly to deliver the assigned project/activity as per timelines.
• Identify process Improvement opportunities and to ensure learning is shared within the TCS team.
• Ensure deliverables and/or agreed activities/tasks with customer. are completed with the expected quality.
Qualifications : BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), MASTER OF PHARMACY
Pharmacovigilance - Mumbai
Job Description
The jobholder is accountable for Independently drafting, negotiating, and finalizing new agreements, and amendments to existing agreements, as per Pharmacovigilance Agreement (PVA) standard operating procedures. This will include the following activities –
• Drafting the agreement based upon approved PVA templates
• Co-ordinating input into agreements from concerned parties
• Compiling agreements
• Determining Companies’ position and negotiating terms of agreement with third parties
• Co-ordinating review cycles and sign-offs
• Implementing agreements
• Maintaining and updating existing agreements as necessary
• Ensuring accuracy and up-to-date information of agreements in the Pharmacovigilance Tracking Database Maintaining status update of all agreements and ongoing work in PV Database
• Managing Safety Data Exchange Agreement (SDEA) queries
Qualifications : BACHELOR OF PHARMACY
Clinical Operations - Mumbai
Job Description : Experience as CRA, CTA, CML, - experience for more than 2-3 years and maximum 5 till years only in clinical research domain. Should be aware of clinical systems, EXAMPLE- Veeva . Good in communication skills, should be able to handle/manage global study team across countries and adaptive for flexible working hours
Qualifications : BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), M.SC., MASTER OF PHARMACY
Skill Details
PV – Case Processor : 1+ Year exp in case processing
Clinical Data Management : 3+ Years exp in CDM activities
Clinical Operations : 2+ Years exp in clinical data operations
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
• Hike letter/Increment Letter of current/previous organization
• UAN Service History Document (downloaded 1 week prior to TCS connect date)
WALK IN INTERVIEW
Saturday, 20th July 2024
Time : 10AM to 3 PM
Contact Person : Supreet Shetty
Location : TCS Mumbai - Vikhroli, Wellspring
Sunday, 21st July 2024
Time: 10AM to 3 PM
Contact Person: Bipin Patel & Nidhi Nigam
Location : TCS Pune- Sahyadri Park
See All B.Pharm Alerts M.Pharm Alerts Ph.D Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
.png)
