Description
Syneos Health is seeking a Sr Safety & PV Specialist to join their team in Madrid. The successful candidate will be responsible for performing safety and pharmacovigilance program delivery activities, including collection, processing, and reporting of individual case safety reports (ICSRs), literature screening and review for safety, drug coding, and data management activities.
The Sr Safety & PV Specialist will ensure that project activities are completed in accordance with agreed timelines, allocated budgets, and required quality standards. They will provide delivery and expertise with minimal oversight and coordinate workflow to ensure delivery of projects.
Key responsibilities include:
- Coordinating workflow to ensure delivery of projects
- Distributing and monitoring team workload
- Escalating issues with project deliverables, finance, and quality to the Safety Program Delivery Lead/Manager or Line Manager as appropriate
- Providing support to manage safety and pharmacovigilance project risks/issues
- Understanding financial measures, work orders, performance metrics, and project budgets
- Assisting in the preparation of project plans and participating in internal project review meetings
- Performing set-up, delivery, and close-out of safety and pharmacovigilance projects
- Maintaining safety tracking for assigned activities
- Processing ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans
- Triaging ICSRs, evaluating ICSR data for completeness, accuracy, and regulatory reportability
- Entering data into safety databases
- Coding events, medical history, concomitant medications, and tests
- Compiling complete narrative summaries
- Assessing information to be queried and following up until information is obtained and queries are satisfactorily resolved
- Participating in the generation of timely, consistent, and accurate reporting of expedited reports
- Coordinating with data management staff concerning reconciliation of safety data between clinical and safety databases
- Performing quality control of literature screening and review for safety, drug coding, and maintenance of drug dictionary
- Validating and submitting xEVMPD product records
- Managing duplicate ICSRs and performing activities related to SPOR/IDMP
- Reviewing ICSRs and performing quality reviews for work performed by peers
- Serving as a subject matter expert in SPVG, including resolution of project-related routine queries, mentoring, and coaching
- Managing a small team within the project
- Ensuring distribution of all required individual expedited and periodic reports
- Providing training to investigators and project team members
- Participating in audits/inspections as required
- Ensuring all relevant documents are submitted to the Trial Master File (TMF) or Pharmacovigilance System Master File
The ideal candidate will have:
- A Bachelor's Degree in life science, registered nurse, pharmacist, or an equivalent combination of education and experience
- Knowledge of safety database systems and medical terminology
- In-depth understanding of clinical trial processes and post-marketing safety requirements
- Proficiency in Microsoft Office Suite, Visio, email, and internet
- Strong communication, presentation, and interpersonal skills
- Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects
- Detail-oriented with a high degree of accuracy and ability to meet deadlines
- Ability to make effective decisions
- Minimal travel may be required (up to 10%)