Job Title: Manager, Safety & Pharmacovigilance (ICSR)
About Syneos Health
At Syneos Health®, we put patients and customers at the center of everything we do. Our clinical development model is designed to simplify and streamline work, making us easier to work with—and easier to work for. With 29,000 employees across 110 countries, we’re united by a passion for accelerating the delivery of therapies to change lives.
Work Here Matters Everywhere.
Why Join Us
Career development and progression opportunities.
Supportive and engaged leadership.
Technical and therapeutic area training.
Peer recognition and total rewards program.
A Total Self Culture where authenticity, diversity, and inclusion are valued.
Key Responsibilities
Leadership & People Management
Lead direct reports, including hiring, training, transfers, utilization, terminations, performance reviews, and professional development.
Provide guidance on administrative policies, technical issues, and workload prioritization.
Monitor team performance, efficiency, and quality of deliverables.
Mentor and train Safety team members; ensure resourcing needs are managed/escalated as necessary.
Project Management & Oversight
Manage Safety & Pharmacovigilance projects as primary services.
Oversee study budgets, expenses, invoicing, and contractual deliverables.
Provide sponsors with scheduled project updates and reports.
Coordinate with cross-functional teams to ensure timely review and submission of safety reports and resolution of issues.
Approve project-related time cards, financials, and invoicing.
Process & Compliance
Develop, review, and approve departmental SOPs.
Ensure execution of Safety Management Plans/Safety Reporting Plans.
Recommend and implement process improvements to increase efficiency and effectiveness.
Maintain compliance with SOPs, WIs, global regulations, ICH, GCP, GVP modules, and study plans.
Ensure inspection readiness and participate in audits/inspections, CAPAs, and quality investigations.
Business Development & Representation
Partner with Business Development to support new opportunities.
Contribute to project proposals and bid defense meetings.
Review safety-related protocol sections, CRFs, and budget projections.
Represent Safety & Pharmacovigilance in project team meetings and client meetings.
Qualifications
Experience:
8+ years in Pharmacovigilance.
5+ years in People Management.
CRO experience with therapeutic specialties (preferred).
Education:
BA/BS in Biological Sciences, Nursing, or related discipline (or equivalent experience).
Technical Skills:
Strong MS Excel skills.
Experience with ARGUS/ARISg Safety Databases (preferred).
Knowledge of SQL / Power BI (desirable).
Proficiency in MS Office Suite, Visio, Outlook, and collaboration tools.
Other Skills:
Leadership and project management abilities.
Strong oral, written, and interpersonal communication skills.
Ability to manage multiple priorities and make effective decisions in dynamic environments.
Knowledge of budgets and financial analysis tools (preferred).
Additional Information
Minimal travel may be required.
Responsibilities and tasks listed are not exhaustive and may change based on business needs.
Syneos Health is committed to diversity, inclusion, equal opportunity, and reasonable accommodations under applicable laws.
About Syneos Health (Quick Facts)
Supported 94% of FDA novel drug approvals in the past 5 years.
Partnered on 95% of EMA authorized products.
Conducted 200+ studies across 73,000 sites and 675,000+ trial patients.
👉 Apply Now or Join our Talent Network to stay connected to future opportunities.
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