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**Description****Safety & Pharmacovigilance Specialist I**Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success.
We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.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**- Enter information into PVG quality and tracking systems for receipt and tracking ICSR.- Assists in the processing of 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.- Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.- Assists in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.- 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 understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process