Margi Levin RN
Media,PA
Overview
2025
2025
years of professional experience
1
1
Certification
Work History
Specialty Submission Planner
MERCK & CO.
Upper Gwynedd, PA
11.2018 - Current
- Led large multifunctional project teams to on-time delivery of Risk Management Plans, Clinical Evaluation Reports, PSUR's, DSUR's, Label Updates, Erratum for distribution to Health Authorities globally
- Created and revised Playbooks/Execution Resources as needed for label updates and clinical evaluation reports
- Mentor new hires/Intern through entry level specifically for Risk Management Plan's and Label Updates
- Support colleagues with specialized knowledge beyond project scope.
Sr. Regulatory
MERCK & CO.
Upper Gwynedd, PA
10.2016 - 11.2018
- Drafted, edited and formatted technical submission ready content for regulatory documents
- Creation and distribution of regulatory dashboard report to executive leadership.
Drug Safety Manager
RPS, INC.
Fort Washington, PA
01.2012 - 06.2012
- Collaborated with Project Manager to ensure the successful execution of the safety requirements for full- service work
- Collaborated with Medical Monitor as required to ensure medical review of adverse events (AE) and serious adverse events (SAE)
Lead Drug Safety Associate
RPS, INC.
Fort Washington, PA
08.2011 - 12.2011
- Delivered initial assessment (triage) and case level review and reconciliation of SAEs and spontaneous reports received in compliance with SOPs and regulatory requirements
- Performed data entry, case processing and MedDRA coding of SAEs and AEs for post marketed products and investigational compounds
- Drafted safety management plans and SOPs
- Provided supportive management to safety associates
Pharmacovigilance Operations Associate
SHIRE PHARMACEUTICALS
Chesterbrook, PA
03.2007 - 06.2011
- Authored, reviewed and revised Safety Data Exchange agreements
- Prepared and distributed contract amendments to license partners globally
- Authored E2b SOP and updated training documents; performed maintenance and storage of all training documents
- Trained all new hires, and internal and external vendors on the Argus Database; managed external vendors
- Implemented a global regulatory reporting requirements spreadsheet
- Submission of expedited reports to Regulatory Authorities globally administered regulatory database
- Identified potential Pharmacovigilance issues using Regulatory Intelligence reports
- Created and implemented metrics spreadsheet for PV Operations use; created metrics spreadsheet for the Data Quality Team; contributed pages and process for a PV Operations 'How To' guide
- Validated and implemented computer systems to maximize the effective use of the global safety system
- Performed data mining, generation of signal detection reports
Drug Safety Associate
COVANCE, INC.
Conshohocken, PA
10.2005 - 03.2007
- Generated, reviewed and updated Adverse Event Reporting Plans
- Accurately processed individual case safety reports by coding adverse events and writing case narratives appropriately via the adverse event databases and tracking systems
- Reviewed adverse events for completeness, accuracy and appropriateness for expedited reporting
- Generated queries directly with sites for follow-up information as well as reviewed queries and query resolution to identify erroneous or incomplete resolution of queries and/or inefficiencies
- Reported expeditable adverse events to clients, investigators and company project personnel, if required, within study specified timelines
- Provided independent QC of AE reports for other members of the group
Registered Nurse, Post-Anesthesia Care Unit
Pennsylvania Hospital
Philadelphia, PA
05.2001 - 09.2005
Registered Nurse, Emergency Room
Mercy Fitzgerald Hospital
Darby, PA
- 01.1999
Registered Nurse, Emergency Room
Chestnut Hill Hospital
Philadelphia, PA
- 06.1998
Education
B.S. - Nursing
Villanova University
B.A. - Political Science
Villanova University
Skills
- Project Management
- Cross-functional coordination
- Program Support
- Cross-Functional Team Leadership
Affiliations
- Figure Skating Coach, Special Olympics of Delaware
Certification
- Registered Nurse - Pennsylvania
Timeline
Specialty Submission Planner
MERCK & CO.
11.2018 - Current
Sr. Regulatory
MERCK & CO.
10.2016 - 11.2018
Drug Safety Manager
RPS, INC.
01.2012 - 06.2012
Lead Drug Safety Associate
RPS, INC.
08.2011 - 12.2011
Pharmacovigilance Operations Associate
SHIRE PHARMACEUTICALS
03.2007 - 06.2011
Drug Safety Associate
COVANCE, INC.
10.2005 - 03.2007
Registered Nurse, Post-Anesthesia Care Unit
Pennsylvania Hospital
05.2001 - 09.2005
- Registered Nurse - Pennsylvania
Registered Nurse, Emergency Room
Mercy Fitzgerald Hospital
- 01.1999
Registered Nurse, Emergency Room
Chestnut Hill Hospital
- 06.1998
B.S. - Nursing
Villanova University
B.A. - Political Science
Villanova University
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