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Open Position

Open Position

PV specialist 사원 - 대리 채용합니다.

  • 2021-07-26 16:43:00
  • 1.223.120.93
  • Support the Implementation and ensure compliance to the Pharmacovigilance (PV) system for medicinal products in Republic of Korea, in compliance with the local national regulations/ standards; Global PV legislation/ standards; and Baxter policies/ procedures at a local, regional and global level.
  • 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.     
  • Continually and proactively improve and develop the PV system and closely work with other departments at a local, regional and global level to meet the needs and requirements of Baxter, and Pharmacovigilance regulations and standards.

PV Operation and Compliance

 

  • Manage the receipt, process and follow-up for adverse event (AE) in the PV safety database as per procedures and regulatory requirements.
  • Submit the AE/SAE to the health authority in according to Korean regulation with translation of documents as required within the required timeframe. 
  • Perform reconciliation activities for AEs and-or safety information exchange , with third parties such Distributors,  call centers vendors,.. and as required
  • Maintain a local calendar for any specific local regulatory report requirements (e.g., AE line listings). Request the required information from local, regional, global functions and submit the reports to authorities as per regulatory requirements.
  • Support Implementation os risk minimization activities locally as required and identify, escalate and communicate all relevant local critical safety issues/ signals.
  • Ensure understanding of the NCR (Nonconformance) and CAPA (Corrective and Preventative Actions) process. Responsible for performing CAPA activities as per identified roles.
  • Support Maintainance audit-ready PV system and operation, and response to  questions at audit/inspection
  • Communicate effectively all relevant safety information and compliance concerns with supervisor and l, escalate to GPS members as per internal procedure, if applicable.
  • Review local SOPs and develop or change as appropriate as per global and regional SOPs, PV guidelines and local regulation.
  • Ensure adherence and appropriate implementation of the local PV BCP (Business Continuity Plan).
  • Prepare and implement local PV staff training matrix to ensure that all aspects of PV training meet local and global requirements. Conduct PV training to employees and third parties.
  • Perform surveillance activities for any new potential safety information (e.g. similar AEs reported in a cluster of reports or multiple cases for one batch received in a short time frame) and escalate as per procedures
  • For third party agreements, perform due diligence and ensure the appropriate PV requirements are incorporated into the agreements. Perform regular review of the agreements to ensure safety requirement are aligned to the current requirement and perform reconciliation of data between the third party

Interaction with team members and stakeholders

 

Interaction with team members and stakeholders

  • Internally closely work with Regulatory Affairs, Medical Affairs, Clinical Operations, Quality Assurance, and Business Unit teams for product safety related issues and collaborate in country initiatives and multi-functional projects.
  • Externally closely work with local regulatory authorities to fully understand the requirement of local implementation of Korean PV regulation and archive all regulatory related correspondence.
  • Participate in  regional or global projects within GPS

Qualifications.  

  • Expert knowledge of the PV relevant local regulations and sound knowledge of international PV relevant regulations and standards (e.g. GVP)
  • Fluent in both written and spoken English
  • Good communication and problem solving skills
  • Time management and project management skills
  • Ability to collaborate with different functions to effect change
  • Ability to work independently and as a team player in a matrix, regional / virtual team environment
  • Bachelor degree or higher in medicine, pharmacy, nurse, veterinary, medical science or an equivalent degree in a scientific field
  • Pharmacovigilance experience of +2 years 

 

 

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