Safety & PV Submission Spec II - (Global Manua

Description Safety & Pharmacovigilance Submissions Specialist II 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 • 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