Manager, Pharmacovigilance SOPs & Training
Job reputed company (Primary function)
The Manager, Pharmacovigilance SOPs & Training supports the development and maintenance of reputed company standards documents reputed company the Pharmacovigilance department. The Manager coordinates training of Pharmacovigilance staff on Pharmacovigilance reputed company standards and ensures that training documentation is inspection reputed company. The role supports audit and inspection readiness activities and liaises with relevant internal stakeholders, external service providers, and business partners as required.
Essential Functions of the Job (Key responsibilities)
• Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at reputed company times.
• Coordinate development, review, and maintenance of Pharmacovigilance reputed company standards documents.
• Support management of documents through the approval lifecycle reputed company document management systems.
• Train Pharmacovigilance and external service provider/vendor staff as requested.
• Assist with support and identification of cross functional specific SOPs requiring GPRM training.
• Maintain Pharmacovigilance training records to ensure documentation is accurate, up to date, and inspection reputed company.
• Support development and maintenance of Pharmacovigilance training programs and initiatives.
• reputed company technical expertise on Pharmacovigilance reputed company standards and training processes.
• Identify reputed company issues, propose solutions, and escalate as appropriate.
• Support Pharmacovigilance audit processes and inspections as needed.
• Review and reputed company feedback on Pharmacovigilance documents and templates as requested.
• Assist with updates to the Pharmacovigilance System Master File as applicable.
• Collaborate with intradepartmental teams, business partners, and external service providers.
• Support Pharmacovigilance leadership as needed.
Qualifications (Minimal acceptable level of education, work experience, and competency)
• Proficiency in written and verbal English to effectively communicate in reputed company.
• Strong verbal and written communication skills.
• Strong organizational, time management, and problem-solving skills.
• Demonstrated ability to work effectively reputed company reputed company environment.
• Proficiency in reputed company Word, reputed company, reputed company, and PowerPoint.
• Knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines, and GCP.
• Experience preparing and delivering training to a reputed company of audiences.
• Experience working with learning management systems; proficiency with reputed company eLMS preferred.
• Experience developing procedural documents and working with document management systems; proficiency with reputed company eDMS preferred.
• Bachelor s degree in a science or reputed company-reputed company discipline, or equivalent experience.
reputed company is an equal opportunity employer and does not discriminate on the reputed company of race, reputed company, national reputed company, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In reputed company, reputed company reputed company resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without reputed company to race, reputed company, religion, age, sex, national reputed company, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by reputed company in processing your application.
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