Dr. Pakki Kausik
Bengaluru
Summary
Pharmacovigilance professional with more than 5 years of experience in end-to-end Individual case safety report (ICSR) processing.
Overview
6
6
years of professional experience
Work History
Pharmacovigilance Services Analyst
Accenture
Bengaluru
09.2024 - Current
- Served as subject matter expert for clinical trial cases.
- Conducted training and quality checks for new team members.
- Tracked production metrics and priorities management in the absence of team lead to ensure workflow continuity.
- Acted as the point of contact for compliance checks and client data protection activities.
- Managed end-to-end processing of individual case safety reports (ICSR) to uphold regulatory compliance.
Drug Safety Associate
Accenture
Bengaluru
07.2021 - 08.2024
- Reviewed and evaluated adverse event case information to determine necessary actions based on internal policies.
- Conducted manual data migration to ensure accuracy of records.
- Encoded verbatims using MedDRA dictionary, products with company product dictionary, and WHO drug dictionary.
- Written comprehensive safety narratives.
- Attached appropriate queries to resolve missing or discrepant information efficiently.
- Executed additional drug safety-related tasks and ad hoc activities as assigned.
Junior Drug Safety Associate
Bioclinica (Clario)
Mysuru
11.2019 - 07.2021
- Managed diverse case types, including serious and non-serious spontaneous, phase 4 and interventional clinical trial cases.
- Codified all medical history, events, drugs, procedures, indications, and laboratory tests using MedDRA and WHO-DD dictionaries.
- Assessed labeling information to ensure compliance with ICSR requirements.
- Written comprehensive safety narratives for various cases.
- Developed queries for missing or inconsistent information to enhance data integrity.
Education
Doctor of Pharmacy -
Avanthi Institute of Pharmaceutical Sciences
Visakhapatnam06.2019
Skills
- Safety database management (ArisG, LSMV, LSMV-NAVAX)
- Attention to detail
- Communication skills
- Time management
- Team collaboration
- Team building
- Adaptability
Hobbies and Interests
- Reading novels
- Writing lyrics (Telugu)
- Writing short-stories
Timeline
Pharmacovigilance Services Analyst
Accenture
09.2024 - Current
Drug Safety Associate
Accenture
07.2021 - 08.2024
Junior Drug Safety Associate
Bioclinica (Clario)
11.2019 - 07.2021
Doctor of Pharmacy -
Avanthi Institute of Pharmaceutical Sciences