Colleen Walsh
Vice President, Global Patient Safety Operations & Systems
- Role
- Vice President, Global Patient Safety Operations & Systems at Alnylam Pharmaceuticals
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Colleen Walsh
Veteran biotech professional with over two decades of experience working in multiple areas of the industry, with a primary focus in pharmacovigilance and quality. Extensive leadership experience at senior levels of small, mid, and large sized organizations. Pragmatic, effective leader in both line and matrixed organizational models with excellent analytical, writing, and team building skills. Expertise in all areas of PV including case management, compliance and quality, regulatory/expedited reporting, aggregate report writing, risk management plans/REMS, clinical trial support (ICF, IB, protocol management), patient registries, and inspection readiness. Inspection lead and primary response author on over 15 global PV/GCP inspections in support of 8 commercial launches.
Experience
Vice President, Global Patient Safety Operations & Systems
Aug 2023 — Present · Cambridge, MA, US
Education
Boston College
Bachelor’s Degree
1994 — 1998
Boston University
Master of Public Health - MPH
Skills
- Clinical Trials
- Pharmacovigilance
- CRO
- Biotechnology
- Pharmaceutical Industry
- Lifesciences
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