Swetha Janagam
King of Prussia,USA
Overview
15
15
years of professional experience
Work History
Safety Data Associate
United BioSource
King of Prussia, USA
06.2022 - Current
- Performed end-to-end case processing for Individual Case Safety Reports (ICSRs), including triage, data entry, quality review, and regulatory submissions.
- Adept at evaluating and prioritizing safety information received from healthcare providers, clinical trial investigators, and consumers.
- Assessed Adverse Events (AEs) and Serious Adverse Events (SAEs) reported through multiple channels such as clinical trials, spontaneous reports, literature, and media.
- Experienced in handling ICSR workflows using global safety databases including ARGUS Safety.
- Applied clinical and regulatory judgment to determine seriousness, causality, and expectedness using reference documents like RSI, SPC, CCDS, and Investigator’s Brochure (IB).
- Utilized knowledge of FDA and ICH-GCP guidelines to perform initial safety case assessments.
- Proficient in generating and reviewing E2B XML transmissions, CIOMS forms, MedWatch forms, and SAE documentation.
- Conducted medical coding of adverse events and medications using MedDRA, WHO drug dictionary, and study-specific conventions.
- Composed detailed narratives and conducted Analysis of Similar Events (AOSE) in compliance with standard operating procedures.
- Performed quality reviews to ensure accuracy, completeness, and consistency in processed ICSRs.
- Executed timely regulatory submissions of safety cases to health authorities and other stakeholders.
- Maintains a strong understanding of global regulatory requirements including FDA, EMA, and ICH-GCP standards.
- Conducted monthly SAE reconciliation activities with vendors and licensing partners to ensure data consistency.
- Monitored pharmacovigilance mailboxes, fax lines, and secure portals daily for the receipt and acknowledgment of safety reports.
- Responsible for booking in reports, performing duplicate checks, and entering accurate case data into the safety database within set timelines.
- Drafted case narratives in accordance with assigned responsibilities and project-specific requirements.
- Ensured all deliverables met quality standards and were completed within required timelines.
- Assisted in the preparation and quality assurance of aggregate safety reports (e.g., PSURs, DSURs), as directed by PV management.
- Supported the timely dissemination of safety reports to regulatory authorities, clients, and business partners in the appropriate formats.
- Facilitated follow-up activities by sending and tracking additional queries related to safety cases in a timely manner.
- Ensured proper documentation and filing of safety reports and associated project materials.
- Contributed to reconciliation processes by ensuring data accuracy and timely completion.
- Assisted in identifying safety cases or relevant information during literature surveillance activities, as delegated.
- Actively participated in department and project-specific meetings and teleconferences.
- Performed additional pharmacovigilance responsibilities as assigned by management.
Drug Safety Intern
Sollers
Edison, USA
08.2021 - 05.2022
- Perform case processing activities for adverse events from receipt to case closure in accordance with ICH-GCP and USFDA regulatory guidelines.
- Focused on initial case assessment to determine validity and triaging cases to prioritize seriousness.
- Data entry of Individual Case Safety Reports (ICSRs) including general information, patient information, medical history, laboratory data, suspect drug, concomitant medications, and adverse event coding into Argus Safety Database and performing quality check of ICSRs.
- Code adverse events and drugs using MedDRA and WHO Drug Dictionary.
- Generate queries to obtain missing case information and clarifications if required in Electronic Data Capture.
- Perform quality review for adverse events (AEs), serious adverse events (SAEs), and serious unexpected serious adverse reactions (SUSARs).
- Perform regulatory submissions according to the provided guidelines.
- Assist with AE/SAE reconciliation prior to database closure.
- Assist with ensuring that periodic and expedited safety reports.
Pharmacy Technician Volunteer
VLV Med Pharmacy
Broadway, USA
05.2014 - 06.2016
- Receive written prescription or refill requests and verify that information is complete and accurate.
- Identify and verify appropriate clinical source documentation for data reporting.
- Prepared prescription label with dosages and expiry date and fixed it in medicine container.
- Contacted physician’s office for any questions regarding prescriptions.
- Establish or maintain patient profiles, including lists of medications taken by individual patients.
- Maintain proper storage and security conditions for drugs.
- Price and file prescriptions that have been filled.
- Receive and store incoming supplies, verify quantities against invoices, check for outdated medications in current inventory, and inform supervisors of stock needs and shortages.
- Processed refills when requested.
- Updated patient information in pharmacy database.
Dentist
Dr.Pavan’s Dental Clinic
Hyderabad, India
10.2010 - 04.2014
- Conducted Clinical Dental Pain Studies to test the effectiveness of new pain reliever medicine from September 2008 to April 2014.
- Assessed the safety and effectiveness of one dose of new pain reliever medicine compared with placebo or acetaminophen after surgical removal of third molars.
- Evaluate pain relief effectiveness up to 6 hours after administration of study drug.
- Performs complex lab experiments and analyzed & reported the data.
- Performed data entry and is responsible for accurate record-keeping records observations and measurements and reports results.
- Overview of systemic review was conducted to evaluate the efficacy or reported adverse events associated with orally administered medication or medication combinations for relief of acute pain.
- Conducted behavioral sciences studies in clinical dental research to examine issues such as patient acceptability of dental treatment and or/preventive procedure with health promotion.
- Conducted research Including clinical trials comparing treatment of dental disease, product quality, and functioning such as that required for biomaterials focusing on quality of healthcare.
Education
Advance Drug safety and Pharmacovigilance (ADSP) -
Sollers College
Edison, NJ01.2022
Bachelor of Dental Surgeon -
Rajiv Gandhi University of Health Sciences
Bangalore, India01.2010
Intermediate Education - Biology, Physics, Chemistry & Zoology
Sri Chaitanya Junior College
Hyderabad, India01.2004
Skills
- Case processing
- Adverse event coding
- MedDRA coding
- Quality review
- Data entry
Current Employer
United BioSource
Years In Industry
8
Therapeutic Areas
- Pediatric dentistry
- Oral pathology
- Maxillofacial surgery
- Hematology
- Pharmacology
- Pain management
Development Phases
Pre & Post-marketing
Major Geographies
- US
- EU
Languages
English Fluent
Training
- IDEM India health conference, 10/23/09, Mumbai, India
- International conference on Medical Negligence and Litigation In Medical Practice, 01/25/10, Tamilnadu, India
- Pedoquest, 33rd ISPPD conference, 11/04/11, Mangalore, India
- Expodenta International India, 12/23/11, New-Delhi, India
- 66th Indian Dental conference, 02/22/13, Kolkata, India
- Indian Dental conference, 02/21/14, Hyderabad, India
Current Position
Safety Data Associate
Licensure Affiliations
- Indian Dental Association (IDA), 08/01/04, Present
- Registered Dental Surgeon, Hyderabad, India
Timeline
Safety Data Associate
United BioSource
06.2022 - Current
Drug Safety Intern
Sollers
08.2021 - 05.2022
Pharmacy Technician Volunteer
VLV Med Pharmacy
05.2014 - 06.2016
Dentist
Dr.Pavan’s Dental Clinic
10.2010 - 04.2014
Advance Drug safety and Pharmacovigilance (ADSP) -
Sollers College
Bachelor of Dental Surgeon -
Rajiv Gandhi University of Health Sciences
Intermediate Education - Biology, Physics, Chemistry & Zoology
Sri Chaitanya Junior College
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