Principal Safety Operations Specialist - Training Lead

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Training

 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

Qualification Criteria -

• 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.
  
  

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.