Job responsibilities
- Coordinates workflow to ensure delivery of project.
- May be responsible for distributing and monitoring team workload.
- Escalates issues with project deliverables, finance and quality to Safety Program Delivery Lead/Manager or Line Manager as appropriate in a timely manner.
- Provides support to manage safety and pharmacovigilance project risks/ issues as required.
- Understands financial measures, work orders, performance metrics (including quality parameters, monthly budget reports, and changes in scope) and project budgets.
- Assists in the preparation of project plans such as Safety Management Plan.
- Assists in the preparation and participates in internal project review meetings as required.
- May perform set-up, delivery, and close-out of safety and pharmacovigilance projects.
- Maintains safety tracking for assigned activities.
- May enter information into SPVG quality and tracking systems for receipt and tracking ICSR.
- May process ICSRs according to Standard Operating Procedures (SOPs) and project/program- specific safety plans.
- Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
- Enters data into safety database.
- Codes events, medical history, concomitant medications, and tests.
- Compiles complete narrative summaries.
- Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
- Participates in the generation of 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.
- May perform or participate in quality control of literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding.
- Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
- Manual recoding of un-recoded product and substance terms arises from ICSRs.
- Identification and management of duplicate ICSRs.
- Activities related to SPOR / IDMP.
- Quality review of ICSRs.
- Quality review for the work performed by peers.
- Serves as a subject matter expert in SPVG, which includes resolution of project related routine queries, mentoring, and coaching.
- Managing a small team within the project.
- Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
- Provides training of Investigators on ICSR reporting or training to project team members for appropriate project related activities.
- Participate in audits/inspections as required.
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
- Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
- Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
Qualifications
What we’re looking for
- Bachelor’s Degree in life science, registered nurse, pharmacist.
- Candidate should have a minimum HSK 4 Level of Certification & above.
- Native Chinese Language Speaker with Degree in Lifescience domain also eligible.
- Safety Database systems and knowledge of medical terminology required
- In depth understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
- Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
- Ability to work independently and in a team environment
- Strong communication, presentation, interpersonal skills, both written and spoken
- 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
- Able to make effective decisions
- Minimal travel may be required (up to 10%)