Primary Responsibilities:
1. Ensures effective functioning of all PV projects in compliance with client agreement.
2. Responsible for safety database creation and maintenance if applicable.
3. Responsible for ensuring global regulatory reporting compliance by execution of processes and compliance with procedures for processing safety reports originating from clinical studies, literature, hotline, regulatory feedback data, social media and/or other sources for post-marketing products.
4. Reviews safety narrative and safety query as needed.
5. Ensures the timely completion and distribution of AE/SAE/SUSAR/ADR/SADR reports and aggregate reports to Health Authorities, client and/or client’s business partners etc..
6. Ensures timely identification of Individual Case Safety Reports and/or relevant safety information during the monitoring of the literature.
7. Monitors and manages the quality, workload, compliance and document across all PV projects.
8. Monitors the processes and workflow and implements process improvements for all projects under his/her responsibility.
9. Regularly reviews project financial status to ensure a good balance between actual delivery and backlog.
10. Keenly identifies services that require change orders and communicates with clients to ensure good financial status.
11. Provides update / progress reports to PV leadership team.
12. Participates in project specific internal and/or external teleconferences/meetings.
13. Attends client operational Face to Face meetings and Investigator meetings as needed.
14. Supports budget proposal, RFI/RFP, preparation and/or attend bid-defense meeting or other meeting as needed.
15. Attends and supports client audits and regulatory inspections from a pharmacovigilance operations standpoint.
16. Be responsible for the recruitment of new staff in PV department, provide the training and mentoring to the new/junior staff.
17. Conducts regular one on one meeting with the direct reports, provide timely feedback and/or comment to the direct reports and help the direct reports to meet organization business target.
18. Timely reviews the direct reports’ time coding, meet the utilization target and keep the finance healthy.
19. Ensures all departmental CVs, job descriptions and training records are complete and up to date per corporate policies.
20. Other ad-hoc tasks assigned by PV leadership team.
Qualifications：
1. Degree in life sciences or a prior experience in PV would be desirable.
2. 3-5 years of experience in PV with both clinical and post-marketing PV experience preferred.
3. Team/staff management experience preferred.
4. Leadership, analytical, and organizational skills preferred.
5. Excellent ability of communication and execution, team spirit.
6. Be familiar with SOPs and relevant regulations e.g. ICH/GCP, NMPA, EMA, FDA and E2A to E2F etc..
7. Strong written and verbal English communication skills.
8. Proficient with computer programs (MS Word, PowerPoint, Excel).
9. Experience in processing safety data within Argus preferred.
10. Ability to manage multiple client projects simultaneously.