Job Summary (Primary function)
The Manager, Pharmacovigilance SOPs & Training supports the development and maintenance of quality standards documents within the Pharmacovigilance department. The Manager coordinates training of Pharmacovigilance staff on Pharmacovigilance quality standards and ensures that training documentation is inspection ready. 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 all times.
- Coordinate development, review, and maintenance of Pharmacovigilance quality standards documents.
- Support management of documents through the approval lifecycle within 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 ready.
- Support development and maintenance of Pharmacovigilance training programs and initiatives.
- Provide technical expertise on Pharmacovigilance quality standards and training processes.
- Identify quality issues, propose solutions, and escalate as appropriate.
- Support Pharmacovigilance audit processes and inspections as needed.
- Review and provide 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 the workplace.
- Strong verbal and written communication skills.
- Strong organizational, time management, and problem-solving skills.
- Demonstrated ability to work effectively within a team environment.
- Proficiency in Microsoft Word, Excel, Outlook, and PowerPoint.
- Knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines, and GCP.
- Experience preparing and delivering training to a variety of audiences.
- Experience working with learning management systems; proficiency with Veeva eLMS preferred.
- Experience developing procedural documents and working with document management systems; proficiency with Veeva eDMS preferred.
- Bachelor’s degree in a science or healthcare-related discipline, or equivalent experience.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, 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 Kaztronix in processing your application.
