Harleen Kaur Saharan
Manager, Safety and Pharmacovigilance
Delhi
Summary
Experienced and results-oriented Safety and Pharmacovigilance professional with 12 years of industry experience, including 9 years at Syneos Health. Proven expertise in managing Individual Case Safety Report (ICSR) processes, leading high-performing teams, conducting quality reviews, and maintaining strong client relationships. Currently supporting European Medicines Agency (EMA) projects, with a focus on ICSR and Duplicate Detection (DD). Highly knowledgeable in regulatory requirements including EMA guidelines, Good Pharmacovigilance Practices (GVP), and ICH-GCP.
Overview
14
14
years of professional experience
Work History
Manager, Safety & Pharmacovigilance
Syneos Health (Erstwhile Kinapse Ltd.)
07.2023 - Current
- Manage a team of 12, overseeing daily operations, performance, and professional development, timecard, leave approvals as well as LMS trainings coordination to ensure high productivity and quality standards.
- Manage full-cycle ICSR operations, including organisation approval, resource allocation, training delivery, query resolution, quality control, and upload at EMA portal
- Quality Lead and Secondary Reviewer for ICSR project
- Represent team in client meetings, prepares agendas, monthly and weekly project reports
- Respond to ServiceNow queries from Marketing Authorisation Holders (MAHs) and National Competent Authorities (NCAs) for the EMA Duplicate Detection Team.
- Act as a Subject Matter Expert (SME) during audits and inspections, providing in-depth knowledge of systems and processes.
- Trained new staff and contributed to the development of team training materials, including project charters and standard operating procedures (SOPs)
- Involved in hiring of new candidates for pharmacovigilance projects
- Support tender submission by preparing few sections and reviewing documentation to ensure accuracy and compliance
- Working on EudraVigilance Web Application (EVWEB), Duplicate Detection client tool, Data Management tracking tool (DMTT), Learning Management System (LMS), ServiceNow dashboard, SharePoint, TransPerfect
Principal Safety & Pharmacovigilance Scientific Specialist
Syneos Health (Erstwhile Kinapse Ltd.)
07.2021 - 06.2023
- Hired associates EMA National competent authorities (NCAs) project
- Led EMA National competent authorities (NCAs) project across multiple NCAs like Romania, Portugal, Slovakia
- Oversaw end-to-end case processing operations, including data extraction from raw Excel files, translations, team allocation, training coordination, query resolution, and ensured on-time project delivery
- Hired, Trained and onboarded new staff and contributed to the development of team training materials, training plan
- Led a team of 30 associates in managing a pharmacovigilance project, overseeing quality reviews and serving as the primary point of contact for client communications
- SME for NCA case processing, DD and ICSR projects
- Worked on EudraVigilance Web Application (EVWEB), Learning Management System (LMS), ServiceNow dashboard, SharePoint, TransPerfect, ARISg
Scientist
Kinapse Ltd.
10.2019 - 06.2021
- Managed a team of 5 and handled ICSR case quality review
- Cross trained resource and worked on multiple roles as ICSR primary and secondary reviewer
- Oversaw DD activities and contributed to project improvements
- Attended EMA audit as SME for DD and ICSR projects in Nov-2018
- Worked on EudraVigilance Web Application (EVWEB), Duplicate Detection client tool, Data Management tracking tool (DMTT)
Senior Associate
Kinapse Ltd.
04.2017 - 09.2019
- Handled quality reviews in ICSR and DD projects (spontaneous, solicited/clinical trial and literature ICSR cases)
- Appointed SME for ICSR and DD, mentored team members
- Led a team of 4 and managed productivity and escalations
- Worked on EudraVigilance Web Application (EVWEB), Duplicate Detection client tool, Data Management tracking tool (DMTT)
Associate
Kinapse Ltd.
05.2016 - 04.2017
- Performed data entry and quality review for DD projects
- Mentored new joiners and gave presentations for team development
- Worked on EudraVigilance, Duplicate Detection client tool, Data Management tracking tool
Drug Safety Specialist
YES Regulatory Healthcare Services Pvt. Ltd.
04.2014 - 05.2016
- Processed spontaneous, solicited/clinical trial and literature ICSR cases
- Performed scientific literature reviews
- Worked with VONE, Vigilit and BaseCon safety databases
Clinical Research Trainee
Panacea Biotec Ltd.
10.2013 - 04.2014
- Understood GVP and ICH guidelines
- Involved in safety evaluation of Paclitaxel
Purchase Executive
Religare Wellness Ltd.
06.2011 - 07.2012
- Managed medicine and surgical purchase orders for hospitals/pharmacies
- Coordinated with wholesalers for timely delivery
Education
MPharm - Pharmacology
Noida Institute of Engineering and Technology
01.2014
BPharm - Pharmacy
Shree Ganpati Institute of Technology
01.2011
Skills
Individual Case Safety Report (ICSR) Management
Pharmacovigilance (PV) & Drug Safety
Client Communication
Team Leadership & Line Management
Quality Review & Compliance (EMA, ICH-GCP, GVP)
Additional Information
EudraVigilance Web Application (EVWEB), ARISg, DMTT, VONE, BaseCon, Vigilit, SharePoint, Microsoft Office, JIRA, ServiceNow, LMS, PDC, TransPerfect
Timeline
Manager, Safety & Pharmacovigilance
Syneos Health (Erstwhile Kinapse Ltd.)
07.2023 - Current
Principal Safety & Pharmacovigilance Scientific Specialist
Syneos Health (Erstwhile Kinapse Ltd.)
07.2021 - 06.2023
Scientist
Kinapse Ltd.
10.2019 - 06.2021
Senior Associate
Kinapse Ltd.
04.2017 - 09.2019
Associate
Kinapse Ltd.
05.2016 - 04.2017
Drug Safety Specialist
YES Regulatory Healthcare Services Pvt. Ltd.
04.2014 - 05.2016
Clinical Research Trainee
Panacea Biotec Ltd.
10.2013 - 04.2014
Purchase Executive
Religare Wellness Ltd.
06.2011 - 07.2012
BPharm - Pharmacy
Shree Ganpati Institute of Technology
MPharm - Pharmacology
Noida Institute of Engineering and Technology
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