A Supervisor in the group works closely with the Head and Managers to ensure that all safety vigilance operation for Santen Medicines and Medical devices is appropriate in terms of structure and performance, to comply with global standards, policies and procedures related to Safety vigilance. Contribute to the global safety vigilance compliance of the company with keeping a 100% compliance from the view of safety database or SV compliance tasks especially in CIS near and middle east Asian, African businesses as well as in European region.
As a supervisor working within the EMEA region, the position holder has the following primary responsibilities. Specific responsibilities may be assigned to individual supervisor within the group:
- Configuration of safety database setting for keeping 100% compliance to the latest regulation for both medicinal product and medical device
- Troubleshooting including communication with the vendor's customer support.
- Summarize and realize local needs through creating "custom report", then contribute to increased efficiency and higher quality by collaboration with SV Pharmaco-epidemiology or SV operation.
- Contribution to a global project of introduction/replacement of safety database system.
- Contribution to vendor management of a partner and the 3rd party for safety vigilance tasks including pharmacovigilance agreement conclusion in CIS, near and middle east Asian, African businesses as well as in European region.
- Contribution to regulatory intelligence in CIS and EMEA with regulatory affairs.
- Assisting with audits and inspections
- Assisting with any activities related to Santen Pharmacovigilance System Master File (PSMF)
- Assisting with any activities related to global/local safety Standard Operating Procedures including creating, reviewing maintaining and updating.
- Assisting with any activities related to SV EMEA Safety Vigilance CAPAs including analysis and assessment of gaps.
- Bachelor's Degree in a Life Sciences discipline required.
- Minimum of 2-3 years of direct experience in a safety vigilance /pharmacovigilance environment within the pharmaceutical industry required.
- Knowledge of medical terminology required.
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Experience of Safety Database system management with the vendors or experience of system launch in SDLC (Software Development Life Cycle) in regardless of safety database.
- Sufficient knowledge of safety vigilance on the basis of the experience of GVP tasks (mainly: ICSR operation) and familiar with regulatory requirements in Europe, Middle East and Africa (EMEA).
Deadline
Please apply no later than 8th November 2024.
To submit your application, please upload your English version of CV (click on Apply and follow the instructions) as we don’t accept Cvs sent directly.
