Pharmacovigilance commissioner
- Work location
- Room A708, Building 1, No.600 Huaxi Road, Minhang District, Shanghai
- Job type
- Management position
- Job responsibilities
- 1, responsible for the company's pharmacovigilance system improvement and maintenance, pharmacovigilance related documents drafting and revision;
2. Participate in the preparation of pharmacovigilance master documents, PSUR, annual review report, DSUR, safety management plan, RMP, RCP and other related documents;
3, timely follow up domestic and foreign pharmacovigilance related norms and regulations, report to the superior leadership;
4. Assisted in the completion of pharmacovigilance system self-test and implementation of rectification plan;
5. Organize or assist in pharmacovigilance related exchanges, education and training;
6. Collection, handling and submission of individual safety reports for clinical trials and post-marketing, including data entry, quality control of data entry and assessment of reportable ICSR, questioning, submission and follow-up.
7. Fully communicate with partner companies, customers and managers on the evaluation and handling process of case reports, and receive the opinions of all parties (including regulators, customers, etc.) on ICSR;
8. Cooperate with other departments to carry out SAE consistency check;
9. Assist the agent in the investigation, communication and handling of customer complaints;
10. Complete other work arranged by superiors
- Qualification
- 1, medicine, pharmacy, epidemiology, nursing or related major, bachelor degree or above;
2, at least 2 years of pharmaceutical or CRO work experience, love pharmacovigilance industry, have a long-term engagement plan;
3, with a high sense of responsibility and execution, serious and responsible attitude;
4, familiar with NMPA, ICH pharmacovigilance requirements and GCP requirements.