Senior Phamacovigilance Specialist

Abbott Laboratories (Malaysia) Sdn Bhd; Selangor; On-site; MYR 100,000 - 150,000; Full time

Job summary

A global healthcare leader in Selangor is looking for a Pharmacovigilance Specialist responsible for ensuring that pharmacovigilance activities meet internal and local regulatory standards. The role involves acting as the local QPPV and maintaining the Affiliate PV systems. Candidates should have a Bachelor's Degree in a relevant field and preferably have experience in pharmacovigilance at a pharmaceutical company. Proficiency in Traditional Chinese is a plus.

Benefits

Career development opportunities

Recognition as a great place to work

Inclusive work environment

Qualifications

• Bachelor's Degree in Pharmacy, Lifesciences or equivalent required.
• Experience in pharmacovigilance within a pharmaceutical company preferred.
• Business-level proficiency in Traditional Chinese is a plus.

Responsibilities

• Act as a local QPPV for Malaysia.
• Maintain the Affiliate PV System Country Chapter.
• Handle PV business continuity planning and notification.

Skills

Pharmacovigilance experience

Computer Software literacy

Business-level proficiency in Traditional Chinese

Education

Bachelor's Degree in Pharmacy or Lifesciences

Tools

MS Office

Excel

Job description

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Imazium Damansara location in the Established Pharmaceuticals Division (EPD). This team is committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

As a Pharmacovigilance Specialist, you ensure 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.

What You’ll Do

• Acts as a local QPPV on a 24/7/365 basis for Malaysia.
• 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.
• Implementation of out-of-office coverage for receiving and recording safety-relevant information.
• 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.

Required Qualifications

• Bachelor's Degree in Pharmacy, Lifesciences or any other equivalent.
• Pharmacovigilance experience in a Pharmaceutical company is preferred.
• Computer Software literacy (MS Office, Excel)
• Preferred qualification: Business-level proficiency in Traditional Chinese to support China/Taiwan regions.

The base pay for this position is

N/A

JOB FAMILY: Product Development

DIVISION: EPD Established Pharma

LOCATION: Malaysia > Selangor : Imazium, No. 8, Jalan SS 21/37

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)