PV Affiliate Drug Safety Associate – at Astellas Pharma, Apply Now!
Are you passionate about patient safety and pharmaceutical innovation? Astellas Pharma, a global leader in the life sciences industry, is hiring a PV Affiliate Drug Safety Associate in Taipei, Taiwan. This critical role offers the opportunity to support pharmacovigilance operations and contribute to drug safety excellence across the region. Explore a rewarding career with a company committed to improving global health.
- Job Posting: PV Affiliate Drug Safety Associate
- Location: Taipei, Taipei City, Taiwan
About the Company – Astellas Pharma
Astellas Pharma is a global pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
Purpose and Scope
In coordination with the PV Affiliate Lead/Drug Safety Officer (DSO) or delegate:
This function is responsible for aspects of excellence in Pharmacovigilance (PV) activities at the local affiliate. Reports to RAPV Affiliate Team Lead Taiwan. Contributes to the successful execution of the local PV objectives and 1-3 year local operational plan, supporting the overall PV mission.
Responsibilities and Accountabilities
ICSR Case Intake and Local Process
- Manage contacts of external and internal customers in matters relating to drug safety.
- Process spontaneous product safety information from various sources.
- Ensure correct use and entry of data in the Global Safety Database (GSD).
- Participate in the development of safety monitoring and reporting plans for local clinical trials.
Local PV Quality Management System
- Maintain appropriate logs and databases for optimal functioning of the local PV department.
- Support with writing and updating of local PV processes and standards.
- Participate in 24/7 availability for handling potential urgent safety issues.
People and Organization Management
- Guide junior colleagues and oversee local PV activities.
- Perform local PV training as needed.
- Develop and maintain effective collaborations with internal and external stakeholders.
Required Qualifications
- Minimum BA/BS in Health Science, Life Science, Medical Science, or equivalent.
- Minimum of 2 years relevant experience in pharmacovigilance or related fields.
- Good knowledge of local PV requirements and regulatory guidelines.
- Excellent time-management and organizational skills.
Skills and Competencies
- Strong sense of urgency and compliance.
- Good communication skills and ability to proactively resolve challenges.
- Customer focus, strategic orientation, innovation, and change mindset.
Preferred Qualifications
- Project management skills.
Working Environment
This position is based in Taiwan and will require on-site work. The hybrid working arrangements are set per Affiliate and incumbent is expected to adhere to local guidelines.
Keywords: Astellas Pharma, Drug Safety Associate, Pharmacovigilance, Taiwan, Job Opening
