Safety & PV Coordinator II - Hybrid, Sofia Area

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

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 sciences

• 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.

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.