JOB DESCRIPTION:

Job Summary:

The Senior PV Specialist for affiliate (Affiliate Safety Representative, ASR) ensures that all activities related to pharmacovigilance (PV) for both Abbott EPD investigational and registered medicinal products are performed at Affiliate level in accordance with internal Abbott policies and procedures as well as with local regulatory requirements. The ASR further is the primary pharmacovigilance interface of Abbott EPD with local health authorities and represents pharmacovigilance internally within the Affiliate organization.

• Working location: Ho Chi Minh city
• Reporting to: Regional PV Manager (SEA)

Core Job Responsibilities:

• Manages and oversees all activities related to pharmacovigilance (PV) at EPD Vietnam to ensure that safety obligations for Abbott EPD investigational and registered medicinal products are fully met. This role is responsible for maintaining compliant PV processes in alignment with Abbott’s internal policies, global procedures and all applicable local regulatory requirements.
  Acts as a local PV responsible person for Vietnam as per local regulatory requirements.
  Ensure the compliant PV processes for Pakistan (including Afghanistan and Bangladesh), and Thailand (including Myanmar, Cambodia, and Laos) by collaborating with the ASR, as an ASR backup. During the absence of the ASR, the ASR backup for Pakistan and Thailand ensures that all activities related to pharmacovigilance.

• Work in collaboration with local non-PV stakeholders to maintain a timely and complete exchange of PV-relevant information, including but not limited to preparation of PV submission packages, Individual Case Safety Report handling, and reconciliation activities.

• Creation and Maintenance of the documents for affiliate pharmacovigilance system such as Affiliate PV System Country Chapter, Pharmacovigilance System Master File as required by local authority and other additional local PV procedures, forms and templates complying with Abbott standards and local regulations.

• PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance. No critical findings in any PV audits or PV inspections

• Contribute to global projects such as LSMV to support global PV affiliates and ensure harmonized and compliant practices.

Knowledge, Experience and Education

• Ideally graduate with a Life Sciences or Pharmacy degree or equivalent qualification
• Years of experience, both overall and any industry-specific experience needed: minimum 7 years in Pharmacovigilance /Medical/Regulatory Affairs experiences in pharmaceutical industry or equivalent experiences
• Understanding of local PV regulation
• Ability to give attention to the detail
• Computer literacy (Windows, MS Office)
• Strong stakeholder management skills, with the ability to build and maintain effective relationships across different levels of the organization
• Ability to work independently, demonstrating strong ownership, accountability, and proactive problem-solving ​
• Good English language skills
• Native speaker – Vietnamese language

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

EPD Established Pharma

        

LOCATION:

Vietnam > Ho Chi Minh City : Me Linh Point Tower

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)