We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Local Person For Pharmacovigilance
- “Contact Person for Pharmacovigilance” towards Thai FDA.
- Being responsible for overseeing the clinical safety and post market safety function of the Thai affiliate office.
- Ensuring PV systems and procedures are appropriately implemented and PV audit / inspection readiness of the Thai affiliate office.
- Oversees and provides input to Quality Events and Corrective and Preventive Actions (CAPAs).
- Preparation and maintenance of local key PV documents including, but not limited to local PSMF, Service
- Level Agreements, local PVAs and PV Business Continuity Plan.
- As required, oversees, and provides input to local Risk Management Plans (RMP) and local Aggregate reports.
- Monitors implementation and effectiveness of additional Risk Minimization Measures.
- Monitors Market Research (MR) and/or Patient Support Programs (PSPs) conducted locally.
- Review protocols for local studies and to define PV related processes for local / area study projects prior to their initiation.
- Manages or oversees local medical literature surveillance.
- Conducts or oversees PV training of all local PV employees, non-PV staff, all sites within the territory, and provide compliance reports.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.