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Mgr, PV

Req #: 180006XT_en
Location: Kuala Lumpur, 14 MY
Job Category: Clinical
Date Posted: 3/22/2018 6:58:49 AM
Baxter International

Description

About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

 

What You’ll Be Doing

 
 
This role is part of the Pharmacovigilance (PV) organization (Global Patient Safety; GPS), and involves responsibilities in regional PV operations and South East (SE) Pharmacovigilance lead.
 
This position is responsible for supporting the implementation of strategies and processes to optimize the cohesiveness of the APAC PV organization and its alignment with GPS.
 
Also to ensure the countries in SE are compliant with local and global PV regulatory requirements, GPS procedures and Baxter policy and standards.
 
This role will also work together with Global GPS and/or APAC and EMEA Regional Director to ensure communication, and coordinate consistent implementation of GPV standards, processes and PV activities between GPS and the LPOs based in the country affiliates.
 
For Singapore
  • Implement and ensure compliance to the Baxter Pharmacovigilance (PV) system for medicinal products in Singapore, 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 Contact Person for Pharmacovigilance for Baxter Singapore, have an oversight of all pharmacovigilance activities as per applicable local legislation
  • Perform appropriate Safety Risk Management activities in Singapore 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 systems 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.
  • Other Responsibilities - Work with local Regulatory Affairs to ensure a calendar of local PSUR (Periodic Safety Update Report) requirements is maintained and these local requirements are communicated to the Global team and met.
  • Provide the appropriate local inputs for the PSMF (Pharmacovigilance Systems Master File) sections.
  • Understand any specific local regulatory report requirements (e.g., AE line listings), request the required information from the Global team and submit the reports to authorities as per regulatory requirements.
For Malaysia, Vietnam, Indonesia, Philippines and Brunei:
  •  Manage and support local Pharmacovigilance personnel on PV activities to be compliant with Baxter requirements and regulations
  • Ensure adequate understanding of audit and inspection preparation and readiness.
  • Ensure all training requirements for the role are met.
  • Support local PV to get alignment and collaboration with local Regulatory Affairs, Medical Affairs, Clinical Operations, Quality Assurance, and Business Unit teams
  • Communicate compliance concerns with, or provide feedbacks regarding local PV activities to, Regional Director PV EMEA and APAC
  • Establish and monitor budgets and forecasts.
 
For APAC Operations Role:
 
Responsibilities include, but not limited to:
 
  • Support the development and implementation of a communication platform for effective and regular communication and networking between APAC LPOs and GPS. Maintenance of APAC regional PV network, e.g., maintenance of LPO contact details, group email list.
  • Coordinate and maintain a regional APAC LPO training program, and take the lead responsibility in performing LPO training, including training of new LPOs, PSS training, and ad hoc training. This also includes managing the ISOtrain software requirements.
  • Act as the regional coordinator for SDEAs/MRPs and PSP.
    • Oversee all APAC Safety Data Exchange Agreement requirements and commitments made to business partners and regulatory authorities. Evaluate any new business agreements in the region to assess and implement the correct PV Language.
    • Maintain the SDEA/MRP/PSP database for the APAC region.
    • Provide support to APAC country and regional Legal concerning review and access to approved APAC SDEA templates
  • Prepare and maintain the operations metrics for the region.
  • To assist in the development and maintenance of relevant PV SOPs and guidance documents
  • Participate in other projects and cross-functional teams as per the discretion of the Regional Director
Takes to build a career here
 
  • Degree in Life Science License (i.e. Pharmacist, Doctor or Oriental Pharmacist)
  • Minimum 3 to 5 years of Pharmacovigilance working experience
  • People Management Skills
  • Project Management Skill
  • Familiarity with international standards and regulations related to PV
 
Why Baxter

A Career That Matters

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.

Call to Action

Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law.

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