Safety & PV Specialist ** Hybrid POLAND **

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:

• 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

Summary: Performs all aspects of the collection, processing, and reporting of adverse events, adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines and study procedures. May progress to leading minimally complex studies.

Essential Functions

• Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance.
• Processes Adverse Events (AEs)/Endpoints according to Standard Operating Procedures (SOPs) and project specific safety plans. Triages AEs, evaluates AE data for completeness, accuracy, and regulatory reportability. Enters data into safety/adjudication database. Performs Quality Control (QC) of entered data/endpoint dossiers. Codes events, medical history, concomitant medications and tests. Compiles complete narrative summaries. Discerns what information requires querying and interacts closely with study monitors, investigative site personnel, and sponsor representatives until all follow‑up information is obtained and queries are satisfactorily resolved. Participates in generation of reports to the sponsor and regulatory authorities; ensures 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.
• Assists safety project lead/endpoint manager in the preparation of a safety management plan.
• Distributes all required periodic reports for both clinical and post‑marketing projects.
• Ensures all aspects of the Company’s safety data collection and processing are consistent with current industry practices and meet all pertinent domestic and international regulatory requirements.
• Maintains current professional knowledge in fields of safety management, coding, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing “value added” expanded company services to all appropriate clients.
• Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.
• Maintains knowledge of ongoing projects and disease‑related terminology.

Other Responsibilities

Performs other work related duties as assigned. Minimal travel may be required.

Requirements

• BA/BS in Life Science or Registered Nurse/Pharmacist.
• Nominal clinical/clinical research experience or equivalent combination of education and experience.
• +2 years Safety and Pharmacovigilance experience is required.
• Clinical Research Organization (CRO) experience with therapeutic specialties preferred.
• Knowledge of safety database preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e‑mail, and internet.
• Some understanding and usage of medical terminology.
• Strong organizational, presentation, documentation, analytical, oral/ written (English), and interpersonal skills with strong judgmentful discretion appropriate to a professional medical setting.
• Ability to make effective decisions, manage multiple priorities, exhibit high degree of accuracy and meet deadlines in a highly dynamic environment.
• Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment.

Disclaimer

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.

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