Syneos Health is looking for a Senior Safety & Pharmacovigilance Submissions Specialist to join our Sponsor-Dedicated team. This is a senior role responsible for processing and oversight of adverse event reports and other safety data for Incyte marketed products and clinical trials. The position involves the full case management lifecycle, quality review, business partner query management, and representing Pharmacovigilance on project teams.
What You'll Do
- Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for Incyte marketed products and clinical trials.
- Complete the full case management lifecycle including intake, triage, book-in, data entry, peer/quality review, follow-up, and submissions.
- Perform case processing and data gathering tasks within the Argus Safety Database and other Incyte systems like EDC systems.
- Assist with literature review and article procurement as required.
- Perform retrospective quality review, document findings, and contribute to metric compilation.
- Assist with business partner and other query management.
- Represent Pharmacovigilance on project teams.
- Assist with CAPA/audit or inspection finding investigations and compile data to support quality and compliance processes.
- Assist with Pharmacovigilance reconciliation of databases and listings from post-marketing and clinical trial sources as required.
- Train and mentor case processing staff.
- Assist with creating procedures (SOPs, Job Aids), forms, and templates to support efficient case management processes.
- Ensure compliance with internal procedures, regulatory requirements, and partner agreements to maintain inspection readiness.
What We're Looking For
- Proven experience in processing and overseeing adverse event reports and safety data for marketed products and clinical trials.
- Comprehensive understanding of the full case management lifecycle from intake to submission.
- Hands-on experience with pharmacovigilance databases, specifically Argus Safety Database.
- Ability to perform quality review, manage queries, and support audit/inspection readiness.
- Experience representing Pharmacovigilance on cross-functional project teams.
- Capability to train and mentor junior members of the case processing team.
- Strong attention to detail and a commitment to following internal procedures and regulatory requirements.
Technical Stack
- Argus Safety Database
- EDC systems
Benefits & Compensation
- Salary range: $67,700.00 - $115,100.00
- Health benefits including Medical, Dental, and Vision
- Company match 401k
- Eligibility to participate in an Employee Stock Purchase Plan
- Eligibility to earn commissions or bonus
- Flexible paid time off (PTO) and sick time
- Potential company car or car allowance
Work Mode
This is a home-based position and candidates must be located on the East Coast of the United States.
Syneos Health is committed to our Total Self culture, passionate about developing our people, dedicated to taking care of our people, and brings together a diversity of thoughts, backgrounds, cultures, and perspectives. We are an equal opportunity employer.
