Kusumakar Patil
Pune
Summary
Pharmacovigilance professional with four years of experience in adverse event management. Skilled in maintaining data integrity and ensuring regulatory compliance across diverse sources. Dedicated and eager to contribute expertise to a dynamic team, ready to join immediately and uphold the highest standards of patient safety.
Overview
4
4
years of professional experience
Work History
Senior Process Associate
Tata Consultancy Services (TCS)
05.2020 - 05.2024
Triaging and Processing of Live ICSR:
- Ensured timely and accurate entry of ICSR data into safety databases, managing average of 400-500 cases monthly.
- Processed wide array of cases from diverse sources, including spontaneous reports, MAP, NIP, digital media, and health authority line listings.
- Conducted thorough evaluations of case reports for completeness, clinical relevance, and adherence to regulatory requirements.
- Authored detailed and clear safety narratives for cases, ensuring accurate reflection of patient events and treatment outcomes.
Perform Follow-up Requests and Query Management:
- Managed and resolved follow-up requests and queries, coordinating with healthcare professionals and stakeholders to gather additional information.
- Maintained high response rate, successfully closing 99% of queries within specified timelines.
Maintaining Trackers for Process and Client Delivery:
- Ensured seamless client delivery by maintaining accurate and up-to-date records, supporting effective communication and reporting.
Training Compliance Monitoring:
- Monitored and reported on team training compliance, ensuring adherence to mandatory training programs and SOPs.
Education
Master of Pharmacy - Pharmaceutics
North Maharashtra University
Shirpur09.2019
Bachelor of Pharmacy -
North Maharashtra University
Chopda06.2017
Skills
- Technical Skills:
- Medical and Clinical Skills:
- Analytical and Problem-Solving Skills:
-Proficient in safety databases, specifically ARISg
-Experienced in using regulatory submission tools such as MedDRA
-Skilled in Microsoft Office applications, including MS Word and MS Excel
-Strong understanding of medical terminology and clinical data interpretation
-Excellent ability to write clear and concise safety narratives that effectively summarize patient events and outcomes
- Communication and Interpersonal Skills:
- Organizational and Time Management Skills:
-Capable of identifying discrepancies in data and resolving queries effectively
-Adept at analyzing complex clinical reports and ensuring regulatory compliance
-Strong verbal and written communication skills, facilitating effective interaction with healthcare professionals and stakeholders
-Proficient in maintaining detailed trackers and reports, ensuring accurate record-keeping
-Excellent at managing multiple tasks simultaneously and meeting deadlines efficiently
Languages
English
Hindi
Marathi
Personal Information
- Father's Name: Mr. Patil Yuvraj Fakira
- Date of Birth: 09/13/95
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Disclaimer
I hereby declare that all the information furnished in my curriculum vitae is true to the best of my belief.
Timeline
Senior Process Associate
Tata Consultancy Services (TCS)
05.2020 - 05.2024
Master of Pharmacy - Pharmaceutics
North Maharashtra University
Bachelor of Pharmacy -
North Maharashtra University
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