Sr Pharmacovigilance Associate III

Name: Sr Pharmacovigilance Associate III
Duration: 1 Year
Location: Remote/Sacramento, CA

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

GPS Document Standards

• Leads procedural document development across the multidisciplined teams and ensure adequate input from cross-functional GPS groups and external business functions.
• Actively ensures collaboration with GPS management, subject matter experts and other functions to develop or revise SOPs and procedural documents and ensures adequate input from business functions.
• Identifies, supports to actively resolve and escalate procedural document-related issues.
• Leads in global harmonization of procedural documents to ensure clarity of content, consistency in application of client's documentation hierarchy and its conventions.

PSMF responsibilities

• Support the end-to-end management of Global and/or Local PSMFs, including data collection, timely receipt of data and supporting documentation for quality control, Veeva workflow management, query resolution and follow-up, logbook generation, and PSMF formatting and publishing.
• Responsible for reviewing PSMF data and ensuring the application of internal core PSMF strategy, to ensure correct data inclusion Responsible for conducting timely quality control checks for each 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 oversight of local PSMFs and variations and deviation to the Core PSMF due to local regulations.

Skills:

• 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 quality management, standards and PSMF maintenance.
• Demonstrated experience with implementing cross-functional partnerships and business processes.
• Strong command of global pharmacovigilance requirements.
• Proficient in Veeva Quality

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.