Principal Safety Operations Specialist - Training Lead
About the role
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.
Training
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
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.
Additional Information
Not included in the source posting: benefits.
Skills
Who can apply
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