Description
Safety & Pharmacovigilance Coordinator (1+ Year Experience in CT or Literature Data Entry)
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
Job Responsibilities
- Monitor and route incoming safety information to the appropriate project teams.
- Record all ICSR documentation and track cases in accordance with sponsor/customer specifications; distribute incoming mail and faxes.
- Redact patient-identifying information and images in compliance with data protection guidelines, ICH-GCP, and GVP requirements.
- Perform accurate and timely data entry into the safety database in accordance with customer-specific guidelines and company standards.
- Assist with case file creation, tracking, retention, and maintenance (paper and electronic).
- Support management of translation processes for source documents requiring translation.
- Assist with query follow-up activities as instructed.
- Support safety submission processes as instructed.
- Assist with daily workflow reconciliation activities.
- Maintain a working knowledge of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP modules, study/program plans, and the drug development process.
Qualification Requirements
- Healthcare professional by education: B.Pharm / M.Pharm / PharmD / BDS.
- Minimum 1 year of experience in Pharmacovigilance in a full data entry / case processing role is mandatory.
- Experience in processing Literature and Clinical Trial (CT) cases is preferred.
- Experience with safety database systems and medical terminology preferred.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, TeamShare (or similar document management systems), and internet applications.
- Strong ability to work collaboratively as part of a team.
- Ability to prioritize and manage multiple tasks effectively in a fast-paced environment.
- Excellent written and verbal communication and interpersonal skills.
- Strong organizational and documentation skills with high attention to detail and accuracy.
- Should be flexible to work in rotational shifts.
Get to know Syneos Health
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.
http://www.syneoshealth.com
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.
Summary
Responsible for assisting with departmental or project deliverables, and with the preparation and the processing of Individual Case Safety Reports (ICSRs), while adhering to all data privacy guidelines, GoodClinical Practices (GCP), regulatory guidelines, and company and project-specific procedures
