Pharmacovigilance Training Manager
Job
Actalent
Remote
$144,997 Salary, Full-Time
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Job Description
Job Description The Manager coordinates training of Pharmacovigilance staff on quality standards and ensures that training documentation is inspection ready. This role supports audit and inspection readiness activities and liaises with relevant internal stakeholders, external service providers, and business partners as required. 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. Essential Skills 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. Additional Skills & Qualifications Training instruction expertise. Pharmacovigilance knowledge. Work Environment This is a remote role primarily based on the East Coast, preferably in NJ, NY, PA, DE, or MD, due to frequent collaboration with EU teams. Candidates should be flexible to work within these time zones. Job Type & Location This is a Contract position based out of Wilmington, DE. Pay and Benefits The pay range for this position is $69.71 - $69.71/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position.
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