Principal Safety Operations Specialist - Training Lead

Job Responsibilities

 Oversees the planning, development, creation and tracking of the training materials (planned or ad hoc) for the Safety and Pharmacovigilance BU. Liaises with Safety and Pharmacovigilance leadership to identify appropriate content for inclusion of new or updated training materials (e.g. Safety Specialist, Safety Coordinator training, revenue recognition, and forecasting training).

 Provides Learning Management System (LMS) oversight for Safety and Pharmacovigilance

 Oversee, review and approve the development of PV specific training for inclusion in an accreditation program

• Bachelor's degree in life science, registered nurse, pharmacist, or equivalent combination of education with below experience qualification.
  

• 8+ years of Pharmacovigilance experience with a strong end-to-end understanding of PV processes and a solid foundation across the safety lifecycle.

• Strong experience in Case Processing, Literature Review, Safety Submissions, Signal Detection, Safety Surveillance, and Aggregate Reporting .
• Should possess end-to-end Pharmacovigilance knowledge with diverse exposure across multiple PV functions and operational processes.
• Training experience is mandatory , including development, review, maintenance, and delivery of training materials/programs for Safety and Pharmacovigilance teams.
• Demonstrated experience in creating training content, conducting instructor-led training sessions, onboarding programs, knowledge transfer initiatives, and capability-building activities .
• Candidates with a combination of PV Operations, Training Management, Learning & Development, and Process Excellence experience will be a strong fit.
• Proven understanding of PV regulations, GVP/GCP requirements, adult learning principles, and training governance.
• Strong team player with the ability to collaborate effectively across global functions while also working independently in an individual contributor role.
Ability to influence stakeholders, drive learning initiatives, and contribute independently without direct people management responsibilities.

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Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.