Syneos HealthSafety & Pharmacovigilance Coordinator II - Based in Sofia Area
Safety & Pharmacovigilance Coordinator II - Based in Sofia Area
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
The position is responsible for assisting with the preparation and the processing of individual case safety reports (ICSR) while adhering to all data privacy guidelines, Good Clinical Practices (GCP), regulatory guidelines, and company and project-specific procedures.
Core Responsibilities:
Monitor and route incoming information to the appropriate project
Records all ICSR documentation and tracks them in accordance with sponsor specifications; distributes incoming mail and faxes.
Redacts patient identifying information/ images in accordance with data protection guidelines and ICH GCPs and GVP.
Enters data into the safety database in accordance with sponsor specific guidelines and Company standards.
Performs file creation, tracking, retention, and maintenance (paper and electronic).
Manage the translation process for any source documents requiring translation.
Requests follow-up safety information as appropriate
Assists with preparing study specific forms/templates Assist with submission processes as instructed
Assist with daily workflow reconciliation
Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/ biologic /device regulations, GCPs, ICH guidelines, and the drug development process
QUALIFICATION and REQUIREMENTS
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.
2+ years of experience in safety/clinical field and knowledge of ICSR case processing flow
Additional and preferred skills: Advanced MedDRA coding training and signal detection management experience
Safety Database systems and medical terminology preferred.
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.
Works with others as part of a team
Ability to successfully prioritize and work on multiple tasks.
Excellent communication and interpersonal skills, both written and spoken and good English level
Strong organizational and documentation skills
Detailed oriented with a high degree of accuracy
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.
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.