Pharmacovigilance supervisor
- Work location
- Room A708, Building 1, No.600 Huaxi Road, Minhang District, Shanghai
- Job type
- Management position
- Job responsibilities
- 1. Responsible for the construction and maintenance of the company's pharmacovigilance system;
2. Organize the preparation or review of pharmacovigilance master documents, PSUR, DSUR, pharmacovigilance plan, annual review report, safety management plan, RMP, RCP, etc.;
3. Write training materials, and conduct training on pharmacovigilance knowledge according to the plan;
4. Processing individual safety reports, including data entry, quality control of data entry and assessment of ICSR rereporting, questioning, submission and follow-up, assisting SAE consistency check;
5. Responsible for the establishment and maintenance of pharmacovigilance database;
6. Responsible for reviewing safety-related documents, such as clinical study protocols, informed consent, investigator manuals, etc.
7. Maintained good communication with the outsourcing company to ensure the continuous compliance of the entrusted pharmacovigilance work, conducted quality control of the entrusted work, and participated in the audit of the entrusted party;
8. Responsible for the investigation and disposal of drug safety emergencies.
9. Complete other work arranged by superiors.
- Qualification
- 1, medicine, pharmacy, epidemiology, nursing or related major, bachelor degree or above;
2. At least 3 years working experience in ophthalmic pharmaceutical company or CRO is preferred;
3, with a high sense of responsibility and execution, serious and responsible attitude, capable of being responsible for pharmacovigilance daily management and compliance operations;
4, familiar with the use of at least one pharmacovigilance database, familiar with NMPA, ICH pharmacovigilance requirements and GCP requirements, received;
5. Have strict logical thinking ability and strong communication and coordination ability.