SWARAJ WANKHEDE
Pune
Summary
Detail-oriented Safety Science Analyst with expertise in ICSR management, safety reporting, and regulatory compliance. Proven ability to track submissions and facilitate stakeholder communication, ensuring adherence to global pharmacovigilance regulations.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Safety Science Analyst ( Submission Specialist)
Fortrea Scientific Pvt.Ltd
Pune
12.2023 - Current
- Submitted individual case safety reports (ICSRs) in compliance with global pharmacovigilance regulations.
- Executed submissions to US FDA, EMA, MHRA, Health Canada, and business partners.
- Facilitated portal submissions via courier and email in CIOMS and MedWatch formats.
- Tracked near due and late cases in collaboration with stakeholders and support desks.
- Monitored failed ICSR submissions, communicating issues to clients and internal stakeholders for resolution.
Clinical Research Coordinator (Internship)
AIIMS
Nagpur
07.2023 - 12.2023
- Managed patient recruitment and informed consent processes, enhancing participant engagement and retention.
- Coordinated clinical trial activities, ensuring strict adherence to protocols and regulatory requirements.
- Maintained accurate documentation of study-related data and records.
- Monitored participant progress and reported adverse events promptly.
- Collaborated with cross-functional teams to streamline research operations.
- Conducted training sessions for new staff on study procedures and regulations.
- Assisted in the preparation of regulatory submissions and audits.
- Facilitated ongoing communication between investigators, sponsors, and participants to promote transparency and address concerns.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
Education
Master of Pharmacy - Medicinal And Pharmaceutical Chemistry
Rashtrasant Tukadoji Maharaj Nagpur University.
Nagpur07-2023
Bachelor of Pharmacy -
Rashtrasant Tukadoji Maharaj Nagpur University.
Nagpur09-2021
Skills
- Safety reporting
- Submission tracking
- ICSR Submission & management
- Regulatory compliance
- Hands on Pharmacovigilance Databases: ARGUS, ARISg and AgXchange (Inbound/Outbound)
- KPI analysis
- Proficient in MS Excel, Word and PowerPoint, Amazon & Windows Workspaces
- Training development
- Case compliance management
- cross-functional collaboration
- protocol adherence
- stakeholder engagement
Languages
English
Upper Intermediate (B2)
B2
Hindi
Proficient (C2)
C2
Marathi
Native
Native
Certification
Pharmacovigilance, Regulatory Affairs & Clinical Data Management
Accomplishments
Delivery Dynamo (top performer of the month)
Timeline
Safety Science Analyst ( Submission Specialist)
Fortrea Scientific Pvt.Ltd
12.2023 - Current
Clinical Research Coordinator (Internship)
AIIMS
07.2023 - 12.2023
Master of Pharmacy - Medicinal And Pharmaceutical Chemistry
Rashtrasant Tukadoji Maharaj Nagpur University.
Bachelor of Pharmacy -
Rashtrasant Tukadoji Maharaj Nagpur University.