Sarah MacMillan
Avon,USA
Summary
ASSOCIATE DIRECTOR, PHARMACOVIGILANCE OPERATIONS
Experienced Paralegal and Project Manager specializing in pharmacovigilance contracts, drug safety training, and compliance. Clinical research background. Accompanied by Lean Six Sigma and Paralegal certifications. Possesses strong communication and organizational skills. Has a proven track record of successfully managing "at risk" cross-functional projects, Safety Data Exchange (Pharmacovigilance) Agreements, and ensuring audit/inspection readiness.
Overview
12
12
years of professional experience
Work History
Associate Director, PV Partnering
Ipsen (acquired Albireo Pharma 02/2023)
03.2023 - Current
- Managed integration of six (6) PV partnerships and >50 contracts from Albireo to appropriate Ipsen personnel, processes, and databases.
- Contributed to post integration hyper-care period and "Lessons Learned" materials for future acquisitions and integrations.
- Managed cross-functional teams for multiple global PV partnerships and creation of SDEAs, successfully executing by target deadlines for new and renewed agreements.
Associate Director, Pharmacovigilance Business Partner Relations
Albireo Pharma
12.2021 - 03.2023
- Authored, negotiate, triaged, and executed six (6) SDEAs with global partners within one calendar year, including development and maintenance of SDEA templates and processes
- Managed PV business partner relationships and associated cross-functional business activities, e.g. Legal and PV Quality/Compliance agreement review
- Oversaw overall operational aspects of global PV alliances and contributed to development and implementation of process improvements for global pharmacovigilance
- Contracted 12/2021 - 6/2022 (FTE hire 6/2022)
SDEA Specialist, PV Operations
GlaxoSmithKline (acquired TESARO 01/2019)
10.2019 - 09.2021
- Managed SDEA and PVA timelines, completeness and compliance with co-developers and license partners
- Managed monitoring of all new, amended and terminated SDEAs from SDEA Team including quarterly reviews and analysis of the PVA database
SDEA Specialist, PV Operations
TESARO
08.2017 - 09.2019
- Designed and managed SDEA/PVA life cycle
- Managed PV contract process improvement: contract templates, SOPs and Work Instructions, and template PV language for legal team
- PV vendor management/communication including vendor training for Adverse Event and Special Situation reporting
- Contributed to audit/inspection readiness and responses
- Contracted 08/2017 - 05/2019 (FTE hire 05/2019)
Sr Project Manager - Safety and Benefit Risk
Biogen
04.2016 - 02.2017
- Audited Biogen SDEA template and life cycle; proposed and executed new SDEA template and workflow
- Managed projects under Safety and Benefit Risk group for queries, SDEAs and audit preparation
- Contracted position
Project Manager Information Systems/Infrastructure
Bain Capital, LLC
02.2015 - 03.2016
- Oversaw change control and vendor management for ISI projects
- The successful delivery of assigned projects on time and within budget, following the system development life cycle and RACI models
- Contracted position
Member Communications Manager
Massachusetts Health Connector
03.2013 - 02.2015
- Successfully managed the Customer Service and Operations - Notices Project (paper communication to Health Connector applicants and members, coverage for both individuals and small businesses, medical and dental insurance)
- Co-Authored, edited and provided quality assurance for the notices sent to applicants and members, ensuring compliance with state and federal regulations
- The MA Health Connector piloted President Barack Obama's Affordable Care Act, this project was part of the rollout and one of the first of its kind in the United States
- Contracted position
Education
Biomedical Science -
University of New Hampshire
Durham, NHParalegal Studies
Northeastern University
Boston, MASkills
- Pharmacovigilance System Master File (PSMF) contributor and reviewer
- Project management and process improvement
- 4 years experience as Corporate Healthcare Paralegal specializing in contract management
- 8 years experience with international colleagues and global business partnerships
- Regulatory compliance
- Strong verbal and written communication
- Inspection readiness
- Risk analysis
Certification
- Lean Six Sigma Green Belt 2017 - William George Associates
- Project Management Professional (PMP/CAPM)
- Agile Coach ICP-ACC2016 - Eliassen Group
- Paralegal Studies Certification
Affiliations
- International Society of Pharmacovigilance
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Associate Director, PV Partnering
Ipsen (acquired Albireo Pharma 02/2023)
03.2023 - Current
Associate Director, Pharmacovigilance Business Partner Relations
Albireo Pharma
12.2021 - 03.2023
SDEA Specialist, PV Operations
GlaxoSmithKline (acquired TESARO 01/2019)
10.2019 - 09.2021
SDEA Specialist, PV Operations
TESARO
08.2017 - 09.2019
Sr Project Manager - Safety and Benefit Risk
Biogen
04.2016 - 02.2017
Project Manager Information Systems/Infrastructure
Bain Capital, LLC
02.2015 - 03.2016
Member Communications Manager
Massachusetts Health Connector
03.2013 - 02.2015
- Lean Six Sigma Green Belt 2017 - William George Associates
- Project Management Professional (PMP/CAPM)
- Agile Coach ICP-ACC2016 - Eliassen Group
- Paralegal Studies Certification
Biomedical Science -
University of New Hampshire
Paralegal Studies
Northeastern University
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