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Local Pharmacovigilance Officer

The Position

Manage the product safety surveillance for the assigned territory by establishing and maintaining a local pharmacovigilance (PV) system compliant with internal procedures and external requirements (e.g. local and international regulations).

 

Task & Responsibilities:

Operational tasks:

  •  Intake, case classification and local review of Patient Safety relevant information in Global Safety Platform.
  •  Provides high quality translation of the case receiving in local language or in case with complex information (where feasible within the required timelines) coordinates the translation with the external vendor, where applicable.
  •  Queries concerning case information (=Follow up) are sent out within the valid BI timelines and properly document in Global Safety Platform.
  •  ICSR Submission to local Health Authorities is performed in line with BI processes and regulatory requirements.
  •  Provide feedback to local Pharmacovigilance (PV) manager any discovered findings on enhancement of ICSR processing process
  •  Reconciliations are performed with all concerned interfaces.
  •  Support of PV training including translation of global training material into local language
  •  Conduct website screening/tests of BI websites regarding the correct reporting of PV relevant information.
  •  Support of local inspections/audits and participation in PV audits and PV inspections as requested.
  •  Screens local scientific literature for identification of PV relevant information.
  •  Give support for local PV Agreements (PVAs) with PV manager’s guidance in cooperation with Global Partner Management
  •  Support of cross-functional colleagues in case of PV process related questions to IIS /NIS / local studies.
  •  Support the implementation of RMP commitments in cooperation with the global and relevant local functions
  •  Support the implementation activities to enhance PV compliance culture and PV awareness at local level of the organization in line with global recommendations
  •  Support the PV manager by the set-up/optimizing of local PV processes including the takeover of subtasks e.g. creation/revision of the related documentation.

 

Requirements:

  • Strong technical knowledge of pharmaceuticals 
  • 2 years or above experience in Pharmacovigilance, Fresh Graduates are welcome
  • Knowledge of local and international pharmacovigilance regulation 
  • Excellent command of English language 
  • Strong written and verbal communication 
  • Proactive and assertive attitude 
  • High standard of interpersonal skills, including the ability to lead teams, to coach individuals, manage conflict constructively, and network 
  • High attention to detail and accuracy 
  • Strong planning and time management skills 
  • Customer service orientation 
  • Balanced decision making  

 

Ready to Contact Us?

Please contact our Recruiting Team:  TW: hrdirecttcm.ph@boehringer-ingelheim.com

  

Position Area

Pharmacovigilance

 

Position Area

Taiwan, Taipei

 

Organization

TW – Boehringer Ingelheim Taiwan Ltd

 

Schedule

Full time                                       

 

 

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