Associate PV Manager-PV Physician (MJ001250)全国

1. 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.
2. Ensures timely identification of Individual Case Safety Reports and/or relevant safety information during the monitoring of the literature.
3. Under the supervise of Pharmacovigilance function head, be responsible for the continued safety assessment, evaluation, and risk management of products or product groups in various stages of clinical development.
4. Medical review of individual case reports, including medical review opinions of adverse events of marketed products and draft SAE narratives during clinical trials, expectedness, causality and seriousness review, company comment writing, MedDRA coding, analysis and mining of safety signals etc..
5. Prepare and/or reviews the DSUR (Development Safety Update Report), PSUR (Periodic Safety Update Report), Benefit risk assessment, Periodic Benefit-Risk Evaluation Report (PBRER).
6. Provides strategic and medical input to project specific safety requirements. Reviews and provides technical input for investigator brochures, protocols, informed consents, RCP/RMP，CSR，final study reports and external data monitoring committees as appropriate.
7. Provides expertise to the medical content of the drug labelling, pharmacovigilance plan and risk minimization activities in the Risk Management Plan.
8. Regularly search literature, master the latest product knowledge, especially safety information, and provide basis for relevant decisions.
9. If necessary, cooperate with internal and external medical experts to exchange medical opinions.
10. Participates in project specific internal and or external teleconferences/meetings.
11. Attends client operational Face to Face meetings and Investigator meetings as needed.
12. Supports budget proposal, RFI/RFP, preparation and/or attend bid-defense meeting or other meeting as needed.
13. Keenly identify services that require change orders and communicate with clients to ensure good financial status.
14. Attends and supports client audits and regulatory inspections from a pharmacovigilance operations standpoint.
15. Other activities/tasks assigned by supervisors.
1. Bachelor’s degree or above in clinical medicine or related majors, a prior experience in doctor would be desirable.
2. 1-3 years of experience in PV physician experience preferred.
3. Ability to assessment and analysis SAE report and prepare DSUR/PSUR.
4. Demonstrate understanding of SOPs and relevant regulations (e.g. ICH/GCP, NMPA, EMA, FDA and E2A to E2F etc..
5. Strong written and verbal English communication skills.
6. Proficient with computer programs (MS Word, PowerPoint, Excel).
7. Experience in Argus and Taimei safety database will be preferred.
8. Ability to manage multiple client projects simultaneously.