Director, Safety and PV

Description
Director, Safety and PV - Technology, Innovation & AI Enablement

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE
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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

Job Responsibilities
A hands‑on leader to build, deliver, and scale technology‑enabled Safety/Pharmacovigilance (PV) solutions for internal SYNH PVG operations and customers. The role orchestrates a partner ecosystem (internal IT, SaaS providers, systems integrators), leads solutioning for RFIs/RFPs and bid defenses, convenes bipartite/tripartite innovation councils with customers and partners, and represents SYNH as a visible thought leader in PV technology.

Responsibilities

• Owns the roadmap and delivery of end to end SPVG solutions across case intake/processing, signal, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics—balancing speed, compliance, and value.
• Leads cross‑functional execution with internal teams and external vendors/SIs; establishes governance, SLAs/KPIs, and validated deployments (CSV, 21 CFR Part 11, EU Annex 11, GAMP 5).
• Serves as solution lead on RFIs/RFPs: reference architectures, delivery models, scope/estimation, commercial constructs, and oral/bid defenses.
• Chairs customer innovation councils; converts problem statements into pilots/PoCs with clear success criteria and scales proven patterns into offerings.
• Publishes points of view, presents at conferences/webinars, and briefs executives on the PV tech landscape (AI/NLP/RPA, data platforms, cloud, real‑world data, advanced analytics).
• Manages a small, senior team; drives portfolio planning, resourcing, budgets, and benefits realization.
• Embeds risk‑based quality, privacy, and security by design; partners closely with QA/Compliance and Data Privacy.

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
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.