Senior Pharmacovigilance Specialist, Pharmaceuticals Division

     

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:

• Maintenance of the Affiliate PV System Country Chapter and additional local PV procedures, forms, and templates
• PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance
• Receipt, recording, and reconciliation of safety information
• Safety surveillance including literature and health authority website screening and preparation of local periodic safety reports and Risk Management Plans
• Regulatory submission of safety information
• Basic PV training of local EPD staff
• PV record retention and archiving
• Implementation of out-of-office coverage for receiving and recording safety-relevant information
• Maintenance of local PV product list
• Ensure PV matters in local interventional studies and local non-interventional organized data collection schemes
• Negotiation and implementation of local commercial pharmacovigilance agreements and local pharmacovigilance
• service agreements
• Due Diligence for product acquisition or in-licensing negotiated by an Affiliate organization
• Provision of local PV Compliance metrics and management of non-compliances
• Coordination/management of PV audits and inspections at the Affiliate level
• Ensure vigilance compliant to local legislation for Abbott EPD products beyond medicinal products such as medical devices and food supplements
• Support in preparation of Health Hazard Assessment/Medical Expert Statements
• Perform PV quality checks requiring four-eye review

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
• Fluent in English
• 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 ​

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

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)