Deputy Head of PV Taiwan

5 days ago

Taipei Taipei City, Taiwan Bayer Full time $104,000 - $130,878 per year

YOUR TASKS AND RESPONSIBILITIES


• Assists in the maintenance of company's compliance with respect to laws, regulations and guidance associated with the licensure of Bayer products with respect to patient safety.


• Assures the correct implementation and observation of all safety related Quality System Documents (QSD) of Bayer referring to local safety activities.


• Contributes to appropriate AE/PTC and device event handling aligned with country set up (i.e. LAM country/ Cluster/ Hub); case receipt, clarification, follow up and reconciliation of AEs and incident reports regarding Bayer products in all therapeutic areas. Submits Individual Case Safety Reports to the local Health Authorities of Taiwan according to the local regulations; provides local support to PTC and counterfeit process.


• Participates in local safety issue and crisis management activities in collaboration with the PVCH.


• Contributes in local safety observation detection and review of local relevant medical literature according with the PV standard operations and procedures.


• Education and training within the local organization; documentation of topics addressed during the training and of participants in the training.


• Provides local support to local Product Technical Complaints and counterfeit process.

WHO YOU ARE


• Advanced life sciences degree, preferably a medical doctor, pharmacist, or equivalent through experience.


• Prior work experience in Pharmacovigilance - 3 to 5 years minimum


• Good command of the English language, team player, ability to take personal responsibility and accountability.


• Good communication and presentation skills.


• Organized, able to multitask effectively.


• Able to build effective working relationships between functions.


• Ideally knowledgeable in Pharmacovigilance relevant regulations.


• Knowledge of major concepts in data management and systems.


• Able to function effectively and successfully in a complex global and multicultural environment


• Job title and job grade are subject to the candidate's qualifications.


• Contributes in assuring the appropriate communication, coordination and alignment between local and Global PV organization.

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