Manager, Pharmacovigilance SOPs & Training

Job Summary

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

• 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

• 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $86,500.00 - $216,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.