More jobs:
Job Description & How to Apply Below
Description
Sr Safety & PV Specialist (Literature Case Processing & Review)
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
Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, Pub Med, Medline) for ICSR identification and safety-relevant information.
Skilled in extracting and summarizing key safety information from identified literature sources
Thorough understanding of creating and validating search strategies for pharmacovigilance purpose.
In depth knowledge of major literature databases such as Embase, Pub Med etc.
Experience in conducting local literature searches and reviews.
Understanding of regulatory requirements with respect to global and local literature.
Coordinating workflow to ensure delivery of project.
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.
Provides training of Investigators on ICSR reporting
Participate in audits/inspections as required
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.
Reviews and provides solutions for issues relating to program delivery or escalates appropriately to the Program Lead / Program Director as required
Support…
Note that applications are not being accepted from your jurisdiction for this job currently via this jobsite. Candidate preferences are the decision of the Employer or Recruiting Agent, and are controlled by them alone.
To Search, View & Apply for jobs on this site that accept applications from your location or country, tap here to make a Search:
To Search, View & Apply for jobs on this site that accept applications from your location or country, tap here to make a Search:
Search for further Jobs Here:
×