Safety & PV Specialist – Hybrid Poland

Updated: Yesterday

Location: POL-Warsaw-Hybrid

Job ID: 25105040

Company Overview

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.

Job Overview

Performs all aspects of the collection, processing, and reporting of adverse events, adhering to data protection guidelines, HIPAA, GCPs, regulatory guidelines and study procedures. May progress to leading minimally complex studies.

Job Responsibilities

• Interfaces between company, sponsors, vendors and other departments in 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 the safety database; performs quality control; codes events, medical history, concomitant medications and tests; compiles narrative summaries; queries stakeholders until all follow‑up information is obtained and resolved; participates in report generation to sponsors and regulatory authorities; coordinates with data management on safety data reconciliation.
• Assists safety project lead/endpoint manager in preparing a safety management plan.
• Distributes all required periodic reports for both clinical and post‑marketing projects.
• Ensures all safety data collection and processing is consistent with industry practices and meets all domestic and international regulatory requirements.
• Maintains current professional knowledge in safety management, coding, computer science, quality assurance, regulatory affairs and medical sciences to provide value‑added services to clients.
• Stays current on SOPs, work instructions, global drug/biologic/device regulations, GCPs, ICH guidelines and the drug development process, and on disease‑related terminology.

Other Responsibilities

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

Qualifications

• BA/BS in Life Sciences or Registered Nurse/Pharmacist.
• Nominal clinical/clinical research experience or equivalent combination of education and experience.
• At least 2 years of safety and pharmacovigilance experience.
• Preferred: CRO experience with therapeutic specialties; knowledge of a safety database.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e‑mail and the internet.
• Some understanding and usage of medical terminology.
• Strong organizational, presentation, documentation, analytical, oral and written English, and interpersonal skills with strong judgment and discretion appropriate to a professional medical setting.
• Ability to make effective decisions, manage multiple priorities, exhibit a 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 listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties or job responsibilities. Equivalent experience, skills, and/or education will also be considered; qualifications of incumbents may differ from those listed in the Job Description. Nothing contained herein should be construed to create an employment contract. All language is intended to fully comply with obligations imposed by the legislation of each country in which the Company operates, including the EU Equality Directive.

EEO Statement

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. We provide reasonable accommodations for applicants with disabilities. Contact: jobs@syneoshealth.com.

Contact Information

Phone: 919-876-9300

Fax: 919-876-9360

Toll-Free: 866-462-7373

Website: http://www.syneoshealth.com