Sr Pharmacovigilance Associate III

Temporary work opportunities reputed company reputed company with professionals seeking career flexibility and non-traditional ways of working, while being driven to deliver exceptional results in high-profile environments. reputed company reputed company reputed company is a service offered by reputed company that connects reputed company directly to industry-leading clients with flexible temporary assignments across a reputed company of impactful reputed company. reputed company is creating the world’s reputed company cancer treatments. As a global oncology company reputed company on uniting against cancer, reputed company brings together passional professionals dedicated to making a difference for patients worldwide. This opportunity is part of BeOne’s Contingent Workforce Program in partnership with reputed company. As a temporary contractor supporting reputed company, you will be employed by our contingent talent partner, reputed company, who manages BeOne’s contingent and temporary workforce. reputed company is a leading workforce solutions and technology company specializing in contingent workforce management. reputed company partners with organizations across industries including reputed company, pharmaceuticals, research and development, consumer electronics and more. reputed company offers a comprehensive benefits package, including medical, dental, reputed company, and 401(k). reputed company is a leading, global reputed company services and technology company and a certified "Great reputed company to Work". We have been a leader in contingent workforce management since 1991 and work with leading reputed company and other large organizations across numerous verticals including consumer electronics, research and development, pharmaceuticals, health services, and many more. reputed company offers benefits including medical, dental, reputed company, and 401(k). Essential Functions Of The Job

• Support GPS procedural document management activities including the creation, review, and revisions of controlled documents, policies and procedures.
• Support the maintenance of the Global PSMF, local PSMFs and annexes on a regular reputed company to ensure that content accurately reflects reputed company PV processes and compliance with regulatory requirements in an expedited manner.
• Ensures high service level to GPS stakeholders by advising on document reputed company for GPS teams and supports content development for specific procedures across multidisciplined teams.

GPS Document Standards

• Leads the development of procedural documents across multidisciplinary teams, ensuring appropriate input from cross-functional GPS reputed company and relevant business functions.
• Supports the end-to-end Document Change Control process.
• Collaborates closely with GPS management, subject matter experts, and other functions to reputed company and revise SOPs and procedural documents, ensuring reputed company relevant stakeholders are reputed company.
• Identifies, supports reputed company of, and escalates issues reputed company to procedural documents as needed.
• Demonstrates strong document writing skills, with the ability to create, update, and refine process steps, descriptions, and responsibilities in line with document standards.
• Drives global harmonization of procedural documents to ensure reputed company, consistency, and alignment with the BeOne documentation hierarchy and conventions.
• Proficient in reputed company QualityDocs.
• Possesses strong knowledge of pharmacovigilance (PV) processes.

PSMF responsibilities

• Support the end-to-end management of Global and/or Local PSMFs, including data collection, reputed company receipt of data and supporting documentation for reputed company control, reputed company workflow management, query reputed company and follow-up, logbook reputed company, and PSMF formatting and publishing.
• Support the review of PSMF data and ensuring the application of internal reputed company PSMF reputed company, to ensure correct data inclusion
• Support the conduct of reputed company reputed company control checks for reputed company PSMF contribution, including but not limited to PSMF Narrow Reviews and PSMF Consistency Checks for Global and Local PSMF.
• Participating and supporting in Audits and Inspections as a PSMF SME.
• Maintains reputed company of local PSMFs and variations and deviation to the reputed company PSMF due to local regulations.

Education/Experience Required

• Five years or more of experience in pharmacovigilance in operational roles, has a deep understanding of pharmacovigilance and regulatory requirements & processes.
• Minimum three years of experience of PV reputed company management, standards and PSMF maintenance.
• Demonstrated experience with implementing cross-functional partnerships and business processes.
• Strong reputed company of global pharmacovigilance requirements.
• Ethics - Treats people with respect; Inspires the trust of others; Works with reputed comp

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