Manager, Pharmacovigilance SOPs – Training

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Ensure adherence to internal procedures, regulatory standards, and partner agreements to maintain inspection readiness.

• Oversee the creation, review, and upkeep of Pharmacovigilance quality standards documentation.

• Facilitate the management of documents throughout the approval lifecycle within document management systems.

• Provide training for Pharmacovigilance and external service provider/vendor personnel as required.

• Assist in identifying and supporting the development of cross-functional specific SOPs that necessitate GPRM training.

• Maintain accurate and up-to-date Pharmacovigilance training records to ensure they are inspection-ready.

• Aid in the creation and maintenance of Pharmacovigilance training programs and initiatives.

• Offer technical expertise regarding Pharmacovigilance quality standards and training procedures.

• Identify quality-related issues, suggest solutions, and escalate matters as necessary.

• Support Pharmacovigilance audit processes and inspections as required.

• Review and provide constructive feedback on Pharmacovigilance documents and templates upon request.

• Assist with amendments to the Pharmacovigilance System Master File as applicable.

• Collaborate with teams across departments, business partners, and external service providers.

⛳️ Requirements

• Proficient in both written and spoken English to communicate effectively in a professional setting.

• Excellent verbal and written communication abilities.

• Strong organizational, time management, and problem-solving skills.

• Proven capacity to function effectively within a team environment.

• Proficient in Microsoft Word, Excel, Outlook, and PowerPoint.

• Familiarity with global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines, and GCP.

• Experience in preparing and delivering training to diverse audiences.

• Background in working with learning management systems; familiarity with Veeva eLMS is preferred.

• Experience in developing procedural documents and utilizing document management systems; familiarity with Veeva eDMS is preferred.

• Bachelor’s degree in a science or healthcare-related field, or equivalent experience.

• Employment with ICON is contingent upon possessing the legal right to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.