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**Description****Safety & Pharmacovigilance 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**- Enters information into PVG quality and tracking systems for receipt and tracking ICSR as required.- May assist in the preparation of the project plans such as Safety Management Plan.- May perform set-up, delivery and close-out of safety and pharmacovigilance projects.- Processes 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.- Maintains safety tracking for assigned activities.- Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required