Senior Industry Leader

Heather has over 20 years’ experience in Pharmacovigilance with expertise in the PV Operations and PV Audit areas. Her PV experience includes the establishment of  PV departments for companies without existing departments and the reengineering of  PV departments for companies in various stages of transition. She has successfully designed and implemented PV systems for small to large size companies in preparation for US and global product launch. The PV Operations activities have ranged from the strategic to tactical with experience in PV inspections with the FDA, EMA, Health Canada, MHRA, ANSM, BfArM and Swiss Medic. PV audit experience includes business partner, vendor, CRO, REMs, and internal PV department audits.