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**Description****Senior Safety & Pharmacovigilance 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**- Coordinating workflow to ensure delivery of project.- Escalates issues with project deliverables, finance and quality to Safety Program Delivery Lead/Manager or Line Manager as appropriate in a timely manner- Has an understanding of financial measures, work orders, performance metrics (including quality parameters, monthly budget reports, and changes in scope) and project budgets.- Prepares Safety Management Plan.- Assists in the preparation and participates in internal project review meetings as required.- May enter information into PVG quality and tracking systems for receipt and tracking ICSR.- May process ICSRs according to Standard Operating Procedures (SOPs) and project/program- specific safety plans.- Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.- Enters data into safety database.- Codes events, medical history, concomitant medications and tests.- Compiles complete narrative summaries.- Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.- Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.- Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases- Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports