Himanshu Deshmukh

Operation Management activity:

• Responsible for managing team operation, team performance.
• Leading project specific SLA’s.
• Responsible for accurate resource capacity planning, inflow management and team utilization. Dealing with client queries, notification, escalations.
• Motivating and encouraging team to achieve team and individual targets.
• Identifying process concerns, challenges and putting action/control plan as per requirements
• Presenting the dashboard data in front of client on weekly basis and internal executive team during the governance meetings.
• Support the standardization and quality of the safety data.
• Participate in inspection and audit interviews, participate in recruitment and selection of the team members.

Medical literature article review, potential signal and safety assessment

• Perform Local literature search activity in local journals from different country.
• Perform literature review of medical literature article to assess valid and invalid ICSR from the literature article retrieve in global and local search.
• Assessing potential new safety findings and signal from medical literature article.
• Assessing PSUR relevant information from medical literature articles.

Intake activity/ICSR case processing

• Accountable for performing accurate data capture for individual case safety reports which can be of spontaneous, clinical sources, literature.
• Interact with the reviewing physician(s) to discuss medical appropriateness of adverse event cases and confirm seriousness and listedness assessments.
• Accountable for sending queries for clarity associated with incoming information if
  required.

Testing and Implementation of Business Applications & PV Automation

Involved in requirement of gathering, analysis, solution design and specification, providing.

support to the development and testing of Business Applications. Impact of various

enhancements and changes in requirements Transforming to E2B(R3) XMl file.

• Oracle Argus Drug Safety v7.0,v8.1.1 Arise Lifesphere MultiVigilance ·
• Drug Safety Triager (DST) _for Literature
• Arisg 6.3 and 6.6

Safety Mailbox Management and Reconciliation.
Daily perform the reconciliation of received items in the safety mailbox. Handle all requests received from health authorities and external business partner

ICSR processing:

• Receive information on adverse events, perform initial checks searches the database to prevent duplicate entries create case file and initialize drug safety reports in the safety database.
• Use medical dictionaries (MedDRA) and business guidance to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case.
• Identify clinically relevant information missing from the case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up requests.
• As needed work with country safety departments, Clinical Safety Scientists to ensure that reports are accurately collected, evaluated, and database.
• Mentor junior staff in pharmacovigilance methodology and in processing different types of cases.

Responsibility:

• Accountable for performing accurate data capture for individual case safety reports which can be of spontaneous, clinical sources, literature.
• Accountable for handling ICSRs disposition of valid items from AgXchange for further processing in ARISg (Case initiations).
• Handling invalid items in IRT appropriately through reference to SOPs, relevant training.
• Responsible for identifying duplicate/invalid ICSRs in ARISg and handling as per relevant SOP.
• Respond to queries from clients (including internal and external) in a timely manner.
• Responsible for ensuring that the individual training records are updated in line with inspection readiness.
• Perform all work in accordance with all established regulatory and compliance and safety requirements. All other duties as assigned.