Medical and Pharmacovigilance Specialist

3 weeks ago

Surry Hills, New South Wales, Australia Blackmores Full time
Job Title: Medical & Pharmacovigilance Associate

We are seeking a highly skilled Medical and Pharmacovigilance Associate to join our team at Blackmores Group. As a key member of our team, you will be responsible for championing product safety and pharmacovigilance for our entities, ensuring compliance with market requirements.

About the Role

The successful candidate will work in office three days a week in Surry Hills/Warriewood and will be responsible for:

  • Receiving, entering, investigating, and drafting case narratives on adverse product experiences
  • Determining and performing case follow-up with reporter/patient/HCP to obtain specific case information
  • Ensuring PV cases are reported to Regulators, Data Exchange Partners, and other stakeholders
  • Consistently complying and adhering to BKL's PV Standard and industry/regulatory requirements
  • Preparing, reviewing, and trending PV reports for internal and external stakeholders
  • Escalating all suspected change in risk/benefit balance to management immediately
  • Liaising with data exchange partners and other stakeholders for safety data collection and reconciliation
  • Performing weekly literature reviews and conducting PV activities as required
  • Being the subject matter expert for all PV activities
  • Developing, implementing, and documenting PV training to internal/external stakeholders
  • Managing and maintaining the BKL PV program and PV section of the QMS system
  • Performing internal PV audits as required

Additionally, you will be responsible for:

  • Drafting, clinically assessing, implementing, and maintaining Ingredient Safety Assessments (ISA) and Product Safety Assessments (PSA)
  • Drafting and providing recommendations for Product Risk Assessments
  • Reviewing and approving documents for the product labels approval process
  • Implementing and maintaining the Product Safety Policy, Standard, and Standard Operating Procedure
  • Being the subject matter expert for all product safety related enquiries
  • Responding to internal and external stakeholder medical enquiries related to product safety
  • Performing internal ISA and PSA audits as required
About Blackmores Group

Blackmores Group is a leading natural health company with a proud Australian heritage, operating in over 13 markets with headquarters and a state-of-the-art manufacturing facility in Australia.

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