|Reference # : ||18-09091
||Title : ||Drug Safety Specialist II|
|Experience Level : ||
||Start Date / End Date : ||10/22/2018 / 10/18/2019
| Description |
|Operations Lead - Pharmacovigilance Alliance & External Affairs|
?This position supports the Global Medical Organization (GMO) Strategic Planning & Oversight (SPO) team in the areas of 1) Pharmacovigilance Alliance Contracting (Client) and Metrics by assisting internal personnel in the creation and maintenance of Pharmacovigilance Agreements (PVAs) and appendices with external partners, maintaining and generating Client metric and report outputs.
?This position provides operational oversight for integration/divestiture activities and/or implementation of safety activities/processes that are defined in PV agreement(s) for the Global Medical Organization and Office of Consumer Medical Safety (OCMS), Alliance and External Affairs team.
?Sets tactical approaches and drive effective project plans/milestones and contributes to and supports operational aspects of AEA team related to management and oversight of tools, metrics and integration/divestiture activities for alliances.
?Maintain and monitor group General Mailbox (Outlook).
?Prepare, update and maintain contact list appendices
?Collect and maintain the relevant metrics describing resource capacity and PVA workload.
?Ensure new/revised PVAs are available for awareness in Client University and monitor the International Contracts Database (ICD) for any potential updates/modifications to pharmacovigilance agreements.
?Facilitate the distribution, tracking, and implementation of PVAs in the execution process
?Plans in collaboration with GMO and OCMS and other impacted functional areas, a seamless hand-over from implementation/divestiture phase to operational phase and documentation of responsibilities for integrations, and divestitures.
?Assist in the communication of defined pharmacovigilance activities to GMO and OCMS functional areas and lead documentation of operational processes and activities to ensure compliance to PV agreements.
?Manage tools that track project details, including completion dates, integration, divestiture and implementation.
?Collaborates with R&D functional areas as identified/applicable related to process improvement/regulation driven changes to procedures to ensure consistency related to PV activities.
?Establish a process flow and determine the data needs for the SPO organization.
?Create and manage tools that track project details, agreements, and departmental metrics.
?A minimum of a bachelor?s degree and/or commensurate pharmaceutical experience in a relevant discipline; Medical/Scientific. Directly-related experience in pharmacovigilance preferred.
?Proven experience in group facilitation - ability to lead and drive teams to make decisions & achieve deliverables within agreed parameters & timelines.
?Strong organizational and coordination skills. Demonstrated experience in program management, preferably in pharmaceutical business environment.
?Excellent negotiation and networking skills.