Heather H.
Lead Commercial Pharmacovigilance Liaison @Organon
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WORK HISTORY
Lead Commercial Pharmacovigilance Liaison @Organon
NJ, US
Pharmacovigilance (PV) Liaison is the point of contact for safety reporting support for Commercial and Marketing programs and implements and performs necessary processes to ensure compliance with Global and US FDA safety requirements and regulations and global standardization. The scope of Commercial and Marketing programs includes but not limited to: Patient Support Programs, Market Research Programs, Social Media, Digital Health Solutions, Unregistered Product Supply to ensure consistency and compliance with reporting AEs to our Company.The Lead is responsible for the review, interpretation and communication of evolving US PV and Global requirements and regulations to impacted stakeholders to ensure the compliant processing of individual case and aggregate safety reporting. Develop relationships across the enterprise to manage Patient Support Programs, Market Research Programs, Social Media, etc. as it relates adverse experience reporting to ensure consistency and compliance with reporting AEs to the company.
EDUCATION
William Paterson University of New Jersey
Bachelor's Degree
ABOUT HEATHER H.
Experienced Pharmacovigilance (PV) operations professional with a demonstrated history of working in the pharmaceuticals industry. Skilled in PV agreements, vendor management, adverse event case processing, PV management of commercial programs including social media and patient support programs, PV audits and inspection readiness. PV knowledge base both Global and US FDA ICH, Good Clinical Practice (GCP), EMEA…Strong operations professional with a Bachelor\'s Degree focused in Nursing from William Paterson University of New Jersey.
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