Pratima Singh
Summary
Passionate registered pharmacist with 9 plus years of professional experience in pharma domain with extensive work experience in management of endpoint Adjudication studies, pharmacovigilance, Project Management and offering 2.5 years of project management and leadership performance. Plans and monitors projects to define scope and enforce adherence to timelines and project specifications,z. Adjudication Project Management (Full Service and Standalone Projects) Budget management, Client management, Audit, QA assessment and EMA inspection experience, CEC Coordinator, contracting, onboarding, KOM and EAS Database training and invoice management for adjudicators. Vendor and other stakeholder management. Project Set –up activities. Develop or perform gap analysis of departmental SOPs or WIs. Developed project specific training for adjudication team staff and Clinical team (CRA/ CTL) for adjudication process Project metrics, KPI Score card for individual team member, Training and mentoring of new or less experienced team members Worked on Databases: Merative (formerly known as IBM Clinical), Inform, Medidata RAVE, VCAS, Argus and AG Mednet.
Drug Safety /Pharmacovigilance Experience: Triage, case processing of non- serious, legal and literature cases, MedDRA Coding of preferred terms.
Overview
11
11
years of professional experience
Work History
Adjudication Project Lead
Fortrea (Formerly Labcorp)
10.2019 - Current
- Manage all aspects of Project Start-up activities including compiling Adjudication Committee membership and development of CEC Charter, Site Endpoint Manual, Adjudication Management Plans
- Provide ongoing functional leadership for Adjudication Services of assigned projects
- Participate in client audit, QA assessment and EMA inspection on behalf of Adjudication Services for assigned studies
- Provide oversight of Adjudication services team activities pertaining to: deliverables, procedures, timelines, scope of work, budget, quality and productivity
- Provide input into Project Forecast and budgets, Change Order, client invoicing and vendor payments
- Manage execution of all aspects of Adjudication workflow pertaining to endpoints processing
- CEC Coordinator on assigned project including Contracting, onboarding, KOM and invoicing of work
- Representing Labcorp Adjudication Services on assigned projects and serving as point of contact
- Work as Quality Compliance member and participate in internal departmental Audit on different projects
- Contribute towards Project Continuation and Improvement plans.
Adjudication Coordinator II
Fortrea (Formerly Labcorp)
10.2019 - 04.2021
- Performed QC Review of assembled dossiers prior to CEC review
- Prepared event adjudication status reports and metrics
- Managed Aging Endpoints
- Assign project work to support team and monitor workflow
- Conducted and drafted meeting minutes Adjudication Services team meetings.
Drug Safety Associate
PAREXEL International
05.2018 - 09.2019
- Worked on end-to-end adjudication process, triaged cases, assembled and submitted events dossiers for Adjudication Committee review
- Participated in UAT Testing
- Created and maintained project specific working files, case report files, project central files
- Performed query management, reconciliation task, deactivation of endpoints
- Worked with translation vendor.
Drug Safety Associate
Quintiles Technologies India PVT Ltd
02.2016 - 04.2018
- Processed serious, non-serious and product complaints cases, special events like pregnancy cases
- Good knowledge of scientific terms and medical terminology
- Worked on labeling, seriousness and causality assessment of events, MedDRA coding.
Practitioner CRM
Concentrix
07.2015 - 02.2016
- Counseled patients regarding lifestyle disorders and advised client medicines to the patient if appropriate.
Pharmacist
08.2013 - 02.2015
- Managed dispensing of prescribed and OTC medicines to patients and instructed about dosage of medicines and food.
Education
Master of Pharmacy -
Sant Gadge Baba Amravati University
Bachelor of Pharmacy - undefined
Solapur University
Skills
Microsoft Wordundefined
License
Registered Pharmacist Number 627, Meghalaya Pharmacy Council, India
Timeline
Adjudication Project Lead
Fortrea (Formerly Labcorp)
10.2019 - Current
Adjudication Coordinator II
Fortrea (Formerly Labcorp)
10.2019 - 04.2021
Drug Safety Associate
PAREXEL International
05.2018 - 09.2019
Drug Safety Associate
Quintiles Technologies India PVT Ltd
02.2016 - 04.2018
Practitioner CRM
Concentrix
07.2015 - 02.2016
Pharmacist
08.2013 - 02.2015
Master of Pharmacy -
Sant Gadge Baba Amravati University
Bachelor of Pharmacy - undefined
Solapur University
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