Sagar Puletipalli

I am currently working as a Validation and Testing Manager for a life sciences GXP agile project, and the following are my responsibilities.

• Identified the scope of functional testing, testing scope, and prepared a validation plan while working on other CSV deliverables.
• Authored OQ scripts, and managed a team of two people.
• Timely completion of stories on the JIRA board without spillover.
• Effective defect tracking mechanism and closely working with developers to bring those defects to resolution.
• Executed scripts on the VM tool and ALM.

Previously worked as a PV-ARTEMIS Incident Manager, and the below are my responsibilities.

• Managing the incident team of three people.
• Managing the incidents and RITMs on a daily basis, and the SLA met is 99% against the target of 85%.
• Conducted weekly incident and monthly governance meetings with the client while maintaining an effective channel of communication.
• Mentored new team members.
• Helping the fellow teammates and providing the inputs for further investigation on the issues.
• Lead the Dictionary upgrade (MedDRA/WHO Drug) activity, connecting with multiple stakeholders for smoother implementation in the VAL and Production environment through standard Change Request.

• Worked as Validation work stream Sub-Lead for Leading pharmaceutical company in the Safety system upgrade project. Enabled newer team members for success by organizing boot camps, knowledge sharing sessions, resolving challenges & creating an efficient pipeline of work breakdown structure.
• Managed and supported end-to-end validation of the Argus Safety system.
• Also worked with my Validation Lead on creating Validation Plan, Validation strategy, Test Protocols, Functional-User Acceptance Test Scripts, SOPs, Risk Assessment documents and Traceability Matrix.
• Authored Operational and Performance Qualification scripts and traced URS and FRS to our OQs and PQs.
• Executing Dry runs to authored scripts.
• Informal reviews and providing feedback to OQs and PQs.
• Executed OQ scripts for Business approval.
• Supported client to perform the User Acceptance testing (UAT).

• I am the SME (subject matter expert) and It is recent technological platform where the cases processed through PV platform needs to be validated and should raise incidents concerning to issues, informs the technical team for the issues and helps to sort out the issues concerned to PV process by collaborating with technical team and helps in smooth run of the process.

• Worked as Quality Check Reviewer and the responsibilities include
• Perform quality check on individual case safety report (ICSRs) entered in ARGUS safety database with reference to the source documents and the document the results using approved ICSR quality scorecards.
• Provide feedback to the individuals and the team on the results of quality checks.
• Identify, support and implement continuous improvement activities.
• Ensure overall compliance towards regulatory requirements and agreed SLAs, KPIs with clients.
• Prepare weekly and monthly reports on Quality checks and share the same with team.

• Worked as Case Intake Expert and Non-serious Case Processing associate and below are my responsibilities
• Responsibilities as Non-serious Case Processing Associate:
• Processing of cases as per quality document which were allocated to us by Leads/Supervisor.
• Coding of adverse events, Medical histories, Procedures, Relevant laboratory tests and results as required (Using MedDRA).
• Identifying new events, Medication errors, Lack of efficacy, Product quality issues, off label use as per the client conventions and notifying the sender of the case.
• Coding of suspect, concomitant, past and treatment drugs (using WHO DD and Company product dictionary) and completing appropriate dosing regimens, indications and action taken fields.
• Sending queries regarding data inconsistencies and communicating approaches taken as per the internal medical discussions and client conventions to third party case senders.
• Performing quality review of safety reports prior to submission to sponsors and regulatory authorities.
• Causality assessment of the reported events.
• Review of local/global source documents to determine regional reportability (Expectedness and Listedness CCDS, EU SmPC, USPI and IB).
• Responsible for writing medically relevant safety narrative and PSUR writing of the case.
• Processing of Case Suppression and Correction cases.
• Responsibilities as Case Intake Expert:
• Thorough duplicate check, checking the drug in our U-Pilot list and creating valid case to avoid unnecessary suppression and nullification.
• Seriousness check of the reported events (IME, AESI list).
• Sending queries for data discrepancies and requests for additional information of the initial/follow-up cases and sending acknowledgement to the sender of the case.