Spec, PVReq # JR - 030172 Location Bangkok, Bangkok Job Category Patient Safety Date posted 11/09/2020
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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
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Essential Duties and Responsibilities
- The territory covered by this role is Thailand, Philippines and Myanmar.
- Implements and ensure compliance to Baxter Pharmacovigilance (PV) system for medicinal products and biologics in Thailand, Philippines and Myanmar, in compliance with the local national regulations/ standards; Global PV legislation/ standards; and Baxter policies/ procedures at a local, regional and global level.
- Act as Local Qualified Person Responsible for Pharmacovigilance (QPPV) in Thailand, per local legislation.
- Support the Qualified person responsible for Baxter Healthcare Philippines Inc. and Qualified person responsible for Claris Lifesciences Philippines, Inc. for managing and maintain PV systems and processes in Philippines.
- Perform appropriate Safety Risk Management activities in Thailand, Philippines and Myanmar in order to assure oversight of medicinal product safety and to ensure that appropriate action be taken when necessary, e.g., implementation of risk management activities.
- Maintain a thorough understanding of and comply with the Baxter Pharmacovigilance Quality system and policies.
- Ensure all safety information at a local level is captured in the Global Pharmacovigilance safety database and submitted to regulatory authorities as per regulatory requirements, within reporting timelines.
- Ensure appropriate liaison with country Medical Affairs, Regulatory Affairs, Clinical, Quality, Business Units, Legal, etc., to ensure Pharmacovigilance input into country strategic planning for products throughout their lifecycle.
- Continually and proactively improve and develop the PV System and department to meet the needs and requirements of Baxter, and Pharmacovigilance regulations and Standards.
- Bachelor’s degree, preferable to Bachelor’s degree in Pharmacy, Nursing, or medical science or equivalent degree in a scientific field
- 1-2 years of industry experience in pharmacovigilance is preferred
- Good verbal and written skills in English and Thai
- Knowledge of PV relevant local regulatory framework, and sound knowledge of international PV relevant regulations and standards.
- Excellent analytical and problem solving skills
- Strong interpersonal skills, time management skills and should be able to work in an inter-country and virtual environment.
- Operates effectively in a team environment
- Ability to work under strict deadlines and changing priorities with some supervision
- Attention to detail
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.