Sushant Kadam
Bothell,WA
Summary
A PMP certified Pharmacovigilance professional with 11 years of experience in drug/clinical safety, including case processing, signal detection, risk management, and regulatory compliance. Demonstrated skills in leading and managing projects, collaborating with cross-functional teams, and delivering high-quality results within deadlines and budgets.
Overview
14
14
years of professional experience
Work History
Case Management Specialist, Pharmacovigilance
Seagen, Inc.
Seattle, WA
10.2022 - Current
- Day-to-day issue management and oversight for Case Corrections Tracker
- Ensure oversight and monthly measurement of Quality Control and Retrospective QA metrics
- Oversee performance monitoring and relay quality metrics to vendors
- Analysis of QC trends including actions/recommendations
- Generate, communicate, and archive report of QC findings
- Special Projects - assisted in special projects including, but not limited to, UAT, review of metrics, QC of ad hoc vendor tasks and maintenance of SharePoint materials
- Audit/inspection response subject matter expert for case related findings
- Support audits and inspections
- Ensure audit CAPAs and other actions/recommendations for ICSR processing, quality-related measures, and compliance issues are completed.
Pharmacovigilance Associate II
Shire acquired by Takeda
Boston, MA
11.2017 - 12.2020
- Managed vendor activities related to ICSR processing
- Quality Review - Performed quality review of ICSR cases and provided appropriate quality improvement feedback to the vendor team
- Compliance Review - Monitored vendor timeliness to ensure compliance to company and global regulatory reporting requirements
- Support and monitor vendor's day-to-day activities and urgently address and/or escalate any issues
- Literature Review Oversight - Managed Literature oversight and perform quality check of literature articles and provide quality improvement feedback to vendor
- Supported the day-to-day running of applications to sustain Drug Safety objectives, including Argus Safety, MedDRA, and Reporting rules, product configuration, license configuration
- Contributed to developing SOPs for Pharmacovigilance/Drug Safety department.
Senior Medical Data Specialist (Medical Coder/Reviewer)
Eisai, Inc.
Woodcliff Lake, NJ
10.2016 - 10.2017
- Responsible for selecting codes using MedDRA and WHODD terminologies, which most accurately describe each panel according to established coding guidelines and conventions
- Responsible for the review of appropriate codes of reported terms in clinical trials, not limited to adverse events, medical history, and medications
- Quantitative analysis and Qualitative analysis
- Reviewed the codes for ICH compliance and adherence to coding guidelines and conventions.
Clinical Safety Associate
Brigham and Women's Hospital, TIMI Study Group
Boston, MA
04.2015 - 10.2016
- Processed domestic and foreign safety reports received from assigned studies, according to ICH-GCP guidelines, regulatory requirements, TIMI SOPs, and departmental policies and procedures
- Exercised judgment to assess incoming case reports and source documentation for seriousness and, completeness, accuracy, legibility, and consistency of information and perform necessary checks for duplicate cases
- Served as a liaison to external contacts such as investigational sites, field monitors, and other study staff around the world to obtain missing, discrepant or additional information/source document for each case using medical and regulatory knowledge
- Performed SAE Reconciliation between Clinical and Safety Databases.
Senior Safety Data Analyst
Sciformix Technologies Pvt. Ltd acquired by Labcorp
Pune (India)
08.2013 - 08.2014
- Managed the receipt and processing of primarily Post-marketing, Spontaneous (serious/non-serious) and Literature cases
- Executed drug safety data management processes - a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, call intake, case follow-up, report preparation and submission to regulatory authorities - with accountability for quality and timeliness of deliverables and responsibility for process improvements.
Clinical Safety Scientist (CSS)
Cognizant Technology Solutions
Mumbai (India)
10.2009 - 07.2013
- Evaluated and QC'ed serious adverse event/Post marketing adverse event report to ensure accurate and consistent data entry and processing from source documents, with emphasis on timelines and quality
- Assessed adverse event reports for seriousness, causality and expectedness as per the investigator brochure/Basic prescribing information/US package insert, consulted the Medical Safety Expert whenever needed
- Participated in bi-weekly trend analysis
- Coordinated the team and took sessions for the junior associates to improve their quality and performance.
Education
Master of Science (MS) in Project Management -
Harrisburg University
01.2019
Master of Science (MS) in Regulatory Affairs for Drugs, Biologics and Medical Devices -
Northeastern University (Boston)
01.2016
Masters in Clinical Research -
Institute of Clinical Research (ICRI) (Mumbai, India)
01.2009
Bachelor of Pharmacy (B. Pharm) -
S.N.I.O.P (Pusad, India)
01.2007
Skills
- ICSR Case Processing and Data Entry
- Quality and Compliance Monitoring
- Vendor Oversight
- Late case investigations
- RCA CAPA
- Literature SME
- Audits and inspections
- Mentoring and training PV associates
- SOP review and authoring
- MedDRA & WHODD coding
Languages
- English, Full Professional Proficiency
- Hindi, Full Professional Proficiency
- Marathi, Native or Bilingual Proficiency
Hobbies and Interests
- Fitness Hiking/Camping
- Cycling Travelling
References
References available upon request.
Timeline
Case Management Specialist, Pharmacovigilance
Seagen, Inc.
10.2022 - Current
Pharmacovigilance Associate II
Shire acquired by Takeda
11.2017 - 12.2020
Senior Medical Data Specialist (Medical Coder/Reviewer)
Eisai, Inc.
10.2016 - 10.2017
Clinical Safety Associate
Brigham and Women's Hospital, TIMI Study Group
04.2015 - 10.2016
Senior Safety Data Analyst
Sciformix Technologies Pvt. Ltd acquired by Labcorp
08.2013 - 08.2014
Clinical Safety Scientist (CSS)
Cognizant Technology Solutions
10.2009 - 07.2013
Master of Science (MS) in Project Management -
Harrisburg University
Master of Science (MS) in Regulatory Affairs for Drugs, Biologics and Medical Devices -
Northeastern University (Boston)
Masters in Clinical Research -
Institute of Clinical Research (ICRI) (Mumbai, India)
Bachelor of Pharmacy (B. Pharm) -
S.N.I.O.P (Pusad, India)
Similar Profiles
Juan FirpoJuan Firpo
Sr. Manager, Desktop Services at SeagenSr. Manager, Desktop Services at Seagen
Johnny MillerJohnny Miller
Sr ServiceNow Administrator at Pfizer (Seagen)Sr ServiceNow Administrator at Pfizer (Seagen)
Silvia SilvaSilvia Silva
MANAGER, EXTERNAL QUALITY OPERATIONS at Pfizer (legacy Seagen)MANAGER, EXTERNAL QUALITY OPERATIONS at Pfizer (legacy Seagen)
Jennifer HallmanJennifer Hallman
Registered Behavior Technician at Avery Behavior Consulting Inc.Registered Behavior Technician at Avery Behavior Consulting Inc.
Sriram IyerSriram Iyer
Delivery Project Manager (LAM Research) at Avanade (Accenture Subsidiary)Delivery Project Manager (LAM Research) at Avanade (Accenture Subsidiary)