Principal Safety PV Ops Spec | PV Quality Operation Lead

Company Safety group accesses (such as ARISg, Clintrace, Sponsor Argus systems)Maintains understanding and ensures compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules and the drug development processLeads the planning, writing, and execution of Safety System Data Migrations and custom reports

Proposals
Facilitates SPVG Annual Gross Profit percentage (GP%) targets by working with the operational SPVG team members to ensure an appropriate understanding of the factors that drive GP% for the SPVG units in RBB.Attends Plan Activation Strategy calls and develops Safety and PVG proposal strategy by liaising with SPVG leadership.Ensures SPVG budget, text, and scope of work for responses to RFPs (Request for Proposals) and RFIs (Request for Information) are accurate and appropriate by working with appropriate SPVG and corporate partners. Solicits input from SPVG team members and other sources to develop the proposal. Liaises with SPVG leadership to identify appropriate named teams for inclusion in proposals.Assists Safety Lead/Manager with changes in scope and budget for SPVG in liaising with the Contracts team as well as Therapeutic BU Project Managers (PMs) and CDS/Safety Project Managers.Responsible for ensuring the development and maintenance template proposal text and SPVG slides with periodic reviewing and updating of SPVG elements.Responsible for the maintenance and updating of the SPVG elements of the costing model including reviewing project budget information on an ongoing basis to ensure hours and tasks in the cost model are realistic when compared with actual project SPVG financial information.Attends meetings such as bid defense meetings (in relation to SPVG proposal sections) and/or Project Hand-Over meetings as needed.

Qualifications

Should 5+ Years of experience in PV ICSR case processingShould 2+ Year of experience in Quality Related activitiesHaving experience in CAPA writing/Audit is added advantageShould have worked on Project related QC activitiesICSR case processing alone experience is not considered and Must have done QR related activities for more than 2 years at Project levelHaving experience in Quality database tools is preferredShould 5+ Years of experience in PV ICSR case processingShould 2+ Year of experience in Quality Related activitiesHaving experience in CAPA writing/Audit is added advantageShould have worked on Project related QC activitiesICSR case processing alone experience is not considered and Must have done QR related activities for more than 2 years at Project levelHaving experience in Quality database tools is preferred