Lynda Baxter Email & Phone Number

Raleigh-Durham, North Carolina Area

Vice President, Partner: Senior Drug Safety & Pharmacovigilance professional with expertise in developing efficient safety processes while maintaining regulatory compliance. Deep industry knowledge for over 15 years and 21 years critical care nursing background facilitates ability to monitor safety data and identify potential risks. Exceptionally skilled in management of safety operations and implementation of initiatives to maximize efficiencies. Extensive experience managing projects in global safety environment to ensure all timelines are met without compromising quality or compliance. Thrive in fast-paced environments that value proactive, collaborative teams.Global Pharmacovigilance Management • Regulatory Compliance • Risk ManagementIndustry experience includes:• Drug Safety/Pharmacovigilance service providers• Contract Research Organizations• Pharmaceutical/medical companies• Safety Database Implementations and Administrations, ESM and Rave Gateway implementations

Chapel Hill, Nc

ESSENTIAL ROLES AND RESPONSIBILITIES Ensures the strategy, direction, and priorities of safety operation activities areachieved. Provides key input on all safety related functions to ensure compliance with globalregulatory requirements, DSN’s standard operating procedures and industry bestpractices for Pharmacovigilance. Interacts with the key stakeholders on matters concerning global safety operations. Presents recommendations on safety issues to the global safety team and escalatesas appropriate to the VP of Global Safety Operations. Oversees activities delegated to DSN global safety operations team by a QPPV. Oversees the maintenance of inspection readiness within global safety operationsand assists the DSN representative for Health Authority Inspection, Client Audits andInternal Process Audits as required. Participate in preparation of business proposals and client presentations and attendmeetings with potential clients as part of business development team as required.

Raleigh-Durham, North Carolina Area