DHAIRYA BHATT
Summary
Detail-oriented pharmacovigilance professional with extensive experience in Individual Case Safety Reports (ICSRs) management, quality control, and regulatory compliance. Proficient in MedDRA coding, narrative writing, and adverse event case processing, with a proven track record of improving accuracy and efficiency through process optimization. Adept at mentoring teams, collaborating with cross-functional stakeholders, and maintaining compliance with Standard Operating Procedures and regulatory timelines. Skilled in managing high workloads, prioritizing tasks effectively, and fostering a culture of excellence in safety reporting.
Overview
3
3
years of professional experience
6
6
years of post-secondary education
Work History
Pharmacovigilance Associate III
APCER LIFE SCIENCES
(for U.S. clients)
04.2022 - 07.2023
- Conducted final quality reviews of Individual Case Safety Reports (ICSRs) in the ARISg database, ensuring compliance with regulatory standards.
- Reviewed diverse case types, including spontaneous, solicited, literature, and clinical trial cases.
- Managed quality reviews for multiple clients simultaneously, demonstrating adaptability and multitasking skills.
- Communicated critical safety information with business partners, maintaining compliance with SDEA timelines.
- Enhanced accuracy through rigorous quality control checks, minimizing errors in ICSR submissions.
- Led cross-functional meetings to address quality challenges and improve collaboration.
- Mentored team members and provided training to align with regulatory standards and project goals.
- Spearheaded process improvement initiatives, streamlining workflows and boosting efficiency.
- Coordinated workloads with management to ensure timely task delivery and adherence to timelines.
Pharmacovigilance Associate II
APCER LIFE SCIENCES
(for U.S. clients)
08.2020 - 03.2022
- Performed book-in/triage and data entry of Individual Case Safety Reports (ICSRs), including simultaneous handling for two clients.
- Proficient in MedDRA coding, narrative writing, and generating follow-up forms and correspondence with healthcare professionals and other manufacturers.
- Ensured adherence to project guidelines and company Standard Operating Procedures, maintaining compliance with regulatory standards.
- Improved case processing times by developing customized templates for common adverse event scenarios, enhancing efficiency without compromising quality.
- Reduced workload backlog by prioritizing high-severity cases and meeting regulatory deadlines during peak periods.
- Oversaw adverse event reporting and conducted follow-ups to ensure timely resolution.
Education
Master Of Pharmacy (Pharmacology)
NIRMA UNIVERSITY
AHMEDABAD, INDIA 07.2018 - 05.2020
Bachelor Of Pharmacy
GUJARAT TECHNOLOGICAL UNIVERSITY
AHMEDABAD, INDIA 07.2014 - 05.2018
Skills
- Pharmacovigilance and Drug Safety
- Individual Case Safety Reports (ICSR) Management
- MedDRA Coding
- Narrative Writing and Medical Documentation
- Adverse Event Reporting and Follow-ups
- Regulatory Compliance and SOP Adherence
- Quality Assurance and Control
- Process Improvement and Workflow Optimization
- Team Mentoring and Training
- Database Management (ARISg)
- Triaging and Duplicate Search
- Time Management and Task Prioritization
- Good Pharmacovigilance Practice (GVP)
- Good Clinical Practice (GCP)
- Stakeholder Collaboration
- Communication and Interpersonal Skills
- Problem-Solving and Analytical Thinking
Accomplishments
- Certificate of Recognition – FY 2021-22
Awarded for outstanding performance and contribution during the fiscal year. - Bright Beginning Adaptability Award – February 2021
Recognized for exceptional adaptability and performance during a challenging transition..
References
References available upon request.
Timeline
Pharmacovigilance Associate III
APCER LIFE SCIENCES
04.2022 - 07.2023
Pharmacovigilance Associate II
APCER LIFE SCIENCES
08.2020 - 03.2022
Master Of Pharmacy (Pharmacology)
NIRMA UNIVERSITY
07.2018 - 05.2020
Bachelor Of Pharmacy
GUJARAT TECHNOLOGICAL UNIVERSITY
07.2014 - 05.2018
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