Sriram Yerroju
Senior Drug Safety Associate
Mississauga,Quebec
Summary
- Detail-oriented, reliable and results-driven professional with over 6 years of experience in drug safety and clinical research.
- Ability to work independently and make autonomous decisions while still being an integral team player in effort to support a unified outcome.
- Passion for Drug safety, Pharmacovigilance, Medical writing and SAS.
Overview
6
6
years of professional experience
6
6
years of post-secondary education
Work History
Operations Specialist
IQVIA
2019.02 - Current
- Responsible for day-to-day drug safety operations, including the management of in-house Serious Adverse Event (SAE) case processing and external pharmacovigilance vendors
- Oversee the Training, mentoring and management of drug safety operations staff
- Act as the safety database (ARISg) administrator working with ARISg to execute system upgrades, conduct user administration testing (UAT) and review data outputs and system reports
- Responsible for the drafting and/or review of SAE case narratives, SUSAR reports (e.g.CIOMS/MedWatch), Clinical Study Report (CSR) patient narratives
- Serve as the drug safety/pharmacovigilance subject matter expert, providing drug safety guidance for product and/or study specific audits
- Develop and maintain drug safety Standard Operating Procedures (SOPs)/jobaids/work instructions, safety management plans, company SAE report form template
- Assist in the review of annual regulatory safety information (e.g. DSUR, Investigator's Brochure) as well as assist with any ad-hoc regulatory questions specific to drug safety
- Closely collaborate with Data Management on SAE reconciliation issues
- · Navigated intricacies of drug safety databases to process adverse event reports.
Junior Data Analyst
Cognizant technology services
2016.07 - 2019.01
- Worked as a quality reviewer for a German based client and have gained expertise on ARISg safety database.
- Responsible for identifying duplicate/invalid ICSRs in ARIS and handling as per relevant SOP.
- Responsible for generating and forwarding appropriate queries and requests for clarification and/or follow up information.
- Accountable for handling ICSRs disposition of valid items into ARIS from IRT for further processing in ARISg (case initiations).
- Sending MedDRA 21.0 requests as needed and discussing with operation physician team regarding the amendment/split and raising queries regarding the events. Narrative writing as per regulatory format.
- Accountable for performing the appropriate clinical assessments (including the assessment of seriousness, labeling and company causality for each adverse event) adhering to SOPs/other controlled documents and regulatory requirements.
- Mentoring the newly joined associates for initiating the receipt items in Inbound receipt Triage (IRT),case processing and Medra coding and have developed a strong grip on team building activities.
- Adhering to productivity, timeline compliance and quality of cases.
Education
Masters in Pharmacy - Pharmaceutical Technology
Vishnu College of Pharmacy
2013.09 - 2015.12
Bachelor of Science - Pharmaceutical Sciences
Andhra University
2009.06 - 2013.04
Skills
Managing the ARISg safety cloud platform (Additional experience on SCEPTRE, ARGUS)
Providing training and coordinating documentation for new and existing drug safety operations associates
Acted as SME with respect to ARISg platform and also have been a part of user acceptance testing team
Accomplishments
- Have played a key role in the transformation of a subsidiary product catalog from client and served as a SME with respect to all the queries during the attrition.
- Received appreciation from the sponsor multiple times with respect to the quality of PASS (Post Authorization Safety Study) cases and honoured with IMPACT award twice in a period of 6 months.
Timeline
Operations Specialist
IQVIA
2019.02 - Current
Junior Data Analyst
Cognizant technology services
2016.07 - 2019.01
Masters in Pharmacy - Pharmaceutical Technology
Vishnu College of Pharmacy
2013.09 - 2015.12
Bachelor of Science - Pharmaceutical Sciences
Andhra University
2009.06 - 2013.04