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Calum Sinclair Location
England, United Kingdom
Calum Sinclair Work
Vice President, Head of Pharmacovigilance @ (July 2018 - Present)
Vice President, Head of Pharmacovigilance and EU QPPV @ (March 2018 - July 2018)
Executive Director, EU QPPV @ (July 2017 - March 2018)
EU QPPV and Head Benefit-Risk Assessment Scientists. @ (March 2015 - July 2017)
Senior Director, PV Scientist Therapeutic Area Head (Rare Diseases). Deputy EU QPPV @ (April 2014 - February 2015)
Director, Pharmacovigilance and Risk Management, Human Genetic Therapy Products. Deputy EU QPPV @ (November 2007 - April 2014)
Associate PVRM Director. Human Genetic Therapy Products. Deputy EU QPPV. @ (June 2007 - November 2007)
Associate Director, PV Operations. Deputy EU QPPV. @ (December 2006 - June 2007)
Senior Manager, Global PV Systems and Operations. Deputy EU QPPV @ (June 2006 - December 2006)
Senior Manager, Drug Safety. Deputy EU QPPV @ Cephalon (June 2005 - June 2006)
Senior UK Drug Safety Officer. Deputy EU QPPV @ Cephalon (June 2004 - June 2005)
Senior Therapeutic Area Pharmacovigilance Scientist (Oncology) @ (October 2001 - June 2004)
Safety Advisor to Pharmacogenetics and Senior Product Safety Scientist @ (October 1998 - September 2001)
Post -Doctoral Research Scientist @ (April 1997 - October 1998)
Calum Sinclair Education
UCL
PhD (Human Genetics)
1994-1998
University of Plymouth
BSc 2.1. Honours (Biological Sciences)
1990-1993
Calum Sinclair Skills
Acquisition Integration
Biologics
Biotechnology
CTMS
Clinical Development
Clinical Trials
Cross-functional Team Leadership
DSMBs
DSURs
Drug Development
Drug Safety
Due Diligence
GVP modules
International Management
Leadership Development
MAA
MAAs
Oncology
PADERs
PBRERs
PSMF
PSURs
Pharmaceutical Industry
Pharmacovigilance
RMPs
Rare Diseases
Regulatory Inspections
SOP development
Team Leadership
Microsoft Excel
Research
Cross Functional Team Leadership
Strategy
Training
Microsoft Word
Calum Sinclair Summary
Calum Sinclair, based in England, United Kingdom, is currently a Vice President, Head of Pharmacovigilance at PTC Therapeutics, Inc.. Calum Sinclair brings experience from previous roles at PTC Therapeutics, Inc. and Shire Pharmaceuticals. Calum Sinclair holds a 1994 - 1998 PhD in Human Genetics @ UCL. With a robust skill set that includes Acquisition Integration, Biologics, Biotechnology, CTMS, Clinical Development and more. Calum Sinclair has 1 emails and 1 mobile phone numbers on RocketReach.
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