Ishwar Wagh
Drug Safety Associate -II
DHULE,MAHARASHTRA
Summary
To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills.
Overview
3
3
years of professional experience
6
6
years of post-secondary education
1
1
Certification
Work History
Drug Safety Associate II
Parexel international Pvt.Ltd.
Bengaluru, India (Remote)
2 2022 - Current
- Boosted efficiency in handling individual case safety reports through meticulous tracking and organization.
- Performed quality control checks on drug safety reports, ensuring accuracy and completeness of information before submission to regulatory authorities.
- Provided support during regulatory inspections, demonstrating strong understanding of compliance requirements.
- Contributed to development of standard operating procedures, promoting consistency in drug safety practices.
- Proactively identified areas for process improvement within drug safety department, leading to increased productivity.
- Participated in ongoing training programs, honing skills necessary for success in field of pharmacovigilance.
- Maintained up-to-date knowledge on relevant regulations and guidelines, ensuring compliance in all aspects of work as Drug Safety Associate.
- Utilized various databases effectively for efficient retrieval and analysis of drug safety data when needed.
- Communicated with internal or external contacts to resolve issues related to case processing.
- Prioritized Reconciliations deliverables to accomplished work in established timeframes.
- Interacted with Various country safety heads to discuss ongoing projects and maintain workflow and timelines.
- Conducted root cause analysis to enhance quality and laboratory processes.
- Improved patient safety by accurately reviewing and processing adverse event reports.
- Performing Quality Review of cases such as Solicited and Non-Solicited Cases.
- Promoted culture focused on patient well-being by actively participating in internal meetings discussing current industry best practices and challenges related to drug safety
- Utilized various databases effectively for efficient retrieval and analysis of drug safety data when needed
- Reconciled discrepancies found during adverse event data entry, resolving issues promptly while maintaining data integrity
- Performed quality control checks on drug safety reports, ensuring accuracy and completeness of information before submission to regulatory authorities
- Collaborated with cross-functional teams to develop risk mitigation strategies for drug products
- Streamlined case management processes, ensuring timely submission of quality reports to regulatory authorities
Drug Safety Associate
WISSEN INFOTECH
Thane, India (Remote)
02.2021 - 10.2021
- Processing cases such as Solicited and Non-Solicited Cases on Sapphire Database
- Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements
- Worked on correction version of ICSR received from Different sources.
- Facilitated effective communication between clinical teams and pharmacovigilance staff for coordinated response efforts.
- Reconciled discrepancies found during adverse event data entry, resolving issues promptly while maintaining data integrity.
- Boosted efficiency in handling individual case safety reports through meticulous tracking and organization.
- Enhanced drug safety monitoring with thorough assessment of case data and identification of potential risks.
- Enhanced drug safety monitoring with thorough assessment of case data and identification of potential risks
- Proactively identified areas for process improvement within drug safety department, leading to increased productivity.
- Conducted comprehensive literature reviews to stay informed on new drug safety findings and trends.
Jr. Medical Coder
GeBBS Healthcare Solution Inc, Aurangabad
Aurangabad, India
10.2019 - 06.2020
- Increased coding accuracy by diligently reviewing medical documentation and applying appropriate codes.
- Promoted teamwork within department through effective communication and collaboration on complex cases.
- Streamlined billing process for faster reimbursement by submitting accurate and timely insurance claims.
Education
S.S.C -
Ekvira Devi Secondary High School, Dhule
Dhule 06.2011 - 07.2012
H.S.C. - H.S.C
Mahajan Junior College, Nashik
Dhule 06.2013 - 07.2014
B-Pharmacy - B-Pharmacy
Matoshri College of Pharmacy, Nashik
Nashik 06.2015 - 06.2019
Skills
Project management experience
Client handling
Problem-Solving
Relation building ability
Critical thinking aptitude
Continuous Improvement Mindset
Technical writing proficiency
Case processing experience
Adverse event reporting
Pharmacovigilance expertise
Task Prioritization
Safety Management
Team building
Personal Information
- Date of Birth: 11/24/1996
- Nationality: Indian
- Marital Status: Single
Certification
Certificate of appreciation for outstanding performance.
Disclaimer
I hereby declare that the information given above is true to the best of my knowledge.
Timeline
Certificate of appreciation for outstanding performance.
02-2024
Drug Safety Associate
WISSEN INFOTECH
02.2021 - 10.2021
Jr. Medical Coder
GeBBS Healthcare Solution Inc, Aurangabad
10.2019 - 06.2020
B-Pharmacy - B-Pharmacy
Matoshri College of Pharmacy, Nashik
06.2015 - 06.2019
H.S.C. - H.S.C
Mahajan Junior College, Nashik
06.2013 - 07.2014
S.S.C -
Ekvira Devi Secondary High School, Dhule
06.2011 - 07.2012
Drug Safety Associate II
Parexel international Pvt.Ltd.
2 2022 - Current