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**Description****Senior Safety & Pharmacovigilance Submissions Specialist**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.
**Job responsibilities**- Collaborate with the Sponsor and internal project management associates on the design, preparation and assembly of the expedited and periodic safety report documents- Participates in project launch activities for safety reporting tasks- Prepares Safety Reporting Plan for safety submissions only projects- Maintain tracking of safety submissions- Provides Sponsor/Customer with expedited and periodic safety report submission status updates, as required- Provides support and advice on expedited and periodic safety report issues to project team/Sponsor as required- File documents according to project specific requirements (electronically or in hard copy as applicable).- Forward completed safety submission documents to clients and other relevant parties- Acts as a point of contact for regulatory issues related to safety submissions- May be responsible for distributing and monitoring team workload- Fosters constructive and professional working relationships with all project team members, internal and external- Assists in the preparation and participates in internal project review meetings as required- Assists in the tracking and measuring of program/project and team progress through collection of cycle time metrics and other key performance indicators (KPIs), related to submissions