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:
- Establish and maintain the Local PV system compliant with local regulations and BI requirements
- Ensure local safety data collection and safety reporting
- Ensure, in the assigned territory, adequate PV training of: BI (and working on behalf of BI) employees & PV related vendors
- Ensure local processes for monitoring of PV system compliance and quality improvement
- Lead the preparation and the conduct of PV inspections in close cooperation with GPV and Quality Medicine function
- Safety surveillance tasks:
- Ensure safety surveillance tasks including regular interaction and exchange of expertise with other local departments that receive PV information
- Continuous monitoring of the benefit-risk profile of products under local responsibility
- Identification in the assigned territory of any information relevant to the safety profile of all international products in collaboration with ROPU PV Head/Regional PV Head/GPV
- Contribution as appropriate at local level for implementation and monitoring of risk minimization measures for all products
- Handling of regulatory safety requests and any other safety inquiries/issues in close collaboration with local management, ROPU and Regional PV Heads and GPV
Requirements:
- Strong technical knowledge of pharmaceuticals
- 2 years or above experience in Pharmacovigilance
- 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