Safety & Pharmacovigilance Submissions Specialist II
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
- #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.
- 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.
- Collaborate with the Sponsor and internal project management associates on the design, preparation and assembly of the expedited and periodic safety report documents
- Assists in study set-up for safety reporting only projects/programs
- Assists in the preparation of the Safety Reporting Plan for safety submissions only projects
- Maintains tracking of safety submissions
- Assists in the preparation of expedited and periodic safety report submission status updates, as required, for Sponsor/Customer
- Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities
- Files documents according to project specific requirements (electronically or in hard copy as applicable).
- Forwards completed safety submission documents to clients and other relevant parties
- Fosters constructive and professional working relationships with all project team members, internal and external
- Assists in the preparation of data for internal project review meetings and participates as required
- Participates in audits as required/appropriate
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
- Maintains an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process
What we’re looking for
- Should has 3-5 yrs of exp in Submissions experience in PV Case Processing
- Having experience in Clinical Trail Submissions is preferred
- Should have good experience in manual submissions
- Having experience for either of US/EU/APAC is considered
Apply through this Link