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.
Job responsibilities
A. Enter information into PVG quality and tracking systems for receipt and tracking ICSR.
B. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
C. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
D. Enters data into safety database.
E. Codes events, medical history, concomitant medications and tests.
F. Compiles complete narrative summaries.
G. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
H. Assists in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
I. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the
J. Pharmacovigilance System Master File for post-marketing programs as appropriate.
K. 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.
Qualifications
What we’re looking for
A. Minimum 2-3.6 years of experience in Data Entry, Post Marketing Surveillance(PMS) and Spontaneous cases
B. Good to have hands on Argus
C. Strong experience of Narrative writing and MedDra Coding
D. Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
E. Safety Database systems and knowledge of medical terminology required
F. Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
G. Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
H. Ability to work independently and in a team environment
I. Good communication and interpersonal skills, both written and spoken
J. Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
K. Detail oriented with a high degree of accuracy and ability to meet deadlines
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
