Prakash Katla

• Responsible to support the maintenance and operation of BioNTech's Global Safety Database for all medicinal products (development and post authorization) and further Safety Systems, if applicable.
• Supported the answering of questions regarding data entry and safety data processing.
• Supported the generation and maintenance of procedural documents, train, and onboard relevant staff to ensure high quality data entry and handling within the Pharmacovigilance' Safety Systems.
• Provided support for proper data extraction for regulatory or analytical purposes from applicable Safety Systems.
• Acted as a key user and administrator of dedicated Safety Systems to support standard users regarding data entry and data processing questions.
• Supported the development of data entry and output processes, as well as user training concepts to comply with business and GxP requirements
• Supported the testing of computerized systems (Computer System Validation) to ensure and correct Safety Data handling.
• Consulted the Head of Safety Systems regarding operational and data migration activities to ensure proper data handling and data integrity.
• Knowledge on the technical aspects and the configuration of the computerized system as well as pharmacovigilance regulations and processes to be able to provide 1st and 2nd level user support for the Safety Systems, with focus on data entry, data handling or data integrity.
• Accountable for the availability and correctness of system specific manuals, in-time user trainings, high-quality and timely response to support requests and maintenance of user accounts.

• Receives (by fax, e‐mail or phone call) and processes individual case safety reports(ICSR) (e.g. serious adverse events (AEs), AEs of special interest, and suspected ADRs from clinical trial, spontaneous and from published reports (e.g. from the literature and Regulatory Authorities)).
  This includes:
  • Tracking of received ICSR
  • Entry of ICSR into company or client safety database
  • Query management
• Generates concise, accurate and well‐written case narratives.
• Performs consistent coding of diseases, AEs, and medications.
• Properly documents all internal and external contacts and communications (e.g. with reporters of cases, sites, or clients whether verbal or written).
• Follows‐up on cases as appropriate.
• Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.
• Quality controls the reportability assessment of ICSR.
• Participates in internal and client project team meetings, including presentation of the safety process at kick‐off and investigator meetings.
• Assess reportability of ICSRs based on the project‐specific Safety reporting Assessment sheet.
• Submits safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project‐specific contractual agreement.
• If SAEs are reported from blinded trials, the DSA assures maintenance of blinded treatment code, specifically when involved in the unblinding for regulatory reporting purposes.

• Handled a team of 15 FTEs
• Ensured compliance of operations with governing regulatory
requirements.
• Ensured delivery of services meets or exceeds Service Level
Agreements (Compliance, Quality and TAT).
• Extensive experience on leaves and allocation of resources
with PV.
• Managed volume peaks and maintained day to day
operations

• Assisted Team Lead/Project Manager/Service Delivery
  Manager in overall project Management, Executed drug
  safety data management processes – a combination of
  medical coding, narrative writing, peer review, case follow‐up, report preparation and submission to regulatory authorities, Workflow management, identify quality error trends, conduct refresher training towards achieving project SLA.

• Processed ICSRs and submitted to health authorities (Clinical trial, PMS, Literature, Device and Legal cases)
• Provided training to new hires
• POC for Quality improvement initiates
• Provided ideas and implemented for process improvement

• Assessing Launching new products in the market
• Sales Achievement
• Customer Support and Customer Service
• Record Keeping and Reporting

• Assessing client needs and present suitable promoted
  products
• Liaising with and persuading targeted doctors to prescribe our products utilizing effective sales skills
• Providing product information and deliver product samples