Senior Safety Surveillance Associate - Remote, UK

Remote

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. W e provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview

As a Senior Safety Surveillance Associate you will be responsible for the receipt, tracking, and processing of safety reports from clinical trials, spontaneous reporters, and other entities as applicable, according to the company's procedures and global drug and device safety regulations and guidelines. You may/will act as the Safety Lead for client study(ies)/project(s).

Specific tasks would include:

• Reviews and analyzes safety report information for completeness, accuracy and regulatory reportability requirements.
• May provide back up for Safety Inbox tasks as needed.
• Evaluates safety case data with an emphasis on medical presentation; may conduct discussions regarding specific patient case data with health care practitioners and Sponsors; contributes to determination of regulatory reporting requirements based upon case data, product information, and ICH, FDA, and country specific guidelines and regulations.
• Prepares safety reports, including preparation of narrative summary within specified project, regulatory, and/or key performance indicator (KPI) timelines.
• Identifies missing/discrepant data (medical and documentation issues), writes queries, addresses queries with site personnel, evaluates query responses, and resolves queries when complete.
• Performs coding of adverse event and medical history terms, concomitant medications, and laboratory test names within the safety database.
  Performs clinical review of data from the Case Report Forms with an emphasis on safety.
• Performs all tasks consistent with department controlled documents and department guidance.
• Escalate questions, issues, and potential risks to line manager, Safety Lead, or project specific Manager Oversight.
• Contributes to configuration specifications of the safety database, including updates.
• Reviews safety information/tables and/or reports for clients and/or regulatory agencies.
• Reconciles safety data with applicable sources as outlined in the Safety Management Plan including identifying and acting on discrepancies, and completing required documentation.
• With guidance, contributes to CRF design, generates the Safety Management Plan, and generates other project related documentation and tools.
• May participate in audit preparation activities.
• Participates in client and project team meetings, as applicable.
• Provides operational and technical guidance and direction to colleagues.
• May serve as a Safety Lead with oversight for small, non-global studies.
• Assists in study start up and close-out with oversight.
• Provides quality review of safety cases.
• Completes Eudravigilance regulatory submissions and distributes Investigator notifications with oversight within regulatory timelines.
• Serves as a Safety Lead for medium to large scale, global, complex studies for multiple clients.
• Develops the Safety Management Plan independently.
• Participates, attends and presents in audit preparation activities and audit meetings.
• Determines configuration specifications for the safety database, including updates.
• Provides feedback on CRF design, and generates project related documentation and tools independently.
• Prepares safety information/tables and/or reports for clients and/or regulatory agencies.
• Contributes to the development of internal processes.
• Provides coaching and training to lower level personnel.
• Presents safety information to clients, delivers presentations at Investigator Meetings, and can participate in meetings with potential clients.
• Provides quality review of safety cases, analysis of quality within programs, and deliver training to team on quality findings.
• Completes Eudravigilance regulatory submissions and distributes Investigator notifications independently within regulatory timelines and reviews study KPI compliance.
• Completes study start and closeout activities independently.

Qualifications

• Bachelor's degree in nursing (B.S.N.), Registered Nurse (R.N.), Doctor of Pharmacy, Health Science degree or other healthcare related field of study and 5+ years safety surveillance experience, or equivalent combination of education and experience. College degree required.
• Advanced knowledge of medical terminology and of GCPs, ICH guidelines, FDA and other applicable country regulations.
• Advanced proficiency in Microsoft Word, Excel, and PowerPoint, Outlook.
• Advanced verbal and writing skills; English + local language, if relevant.
• Knowledge of Safety database software and related software functionality

If you're passionate about clinical trials, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.