Medical and Pharmacovigilance Associate

1 month ago

Surry Hills, New South Wales, Australia Blackmores Full time
About the Role

We are seeking a highly skilled and experienced Medical and Pharmacovigilance Associate to join our team at Blackmores Group. As a key member of our Pharmacovigilance and Product Quality team, you will play a critical role in ensuring the safety and quality of our products.

Key Responsibilities
  • Champion activities related to product safety and pharmacovigilance for Blackmores Group entities, ensuring compliance with regulatory obligations and industry standards.
  • Receive, enter, investigate, and draft case narratives on adverse product experiences, and determine and perform case follow-up with reporters/patients/HCPs.
  • Prepare, review, and trend PV reports for internal and external stakeholders, and escalate all suspected changes in risk/benefit balance to management.
  • Develop, implement, and document PV training to internal/external stakeholders, and manage and maintain the BKL PV program and PV section of the QMS system.
  • Draft, clinically assess, implement, and maintain Ingredient Safety Assessments (ISA) and Product Safety Assessments (PSA) for products across Blackmores Group.
Requirements
  • A qualified and registered pharmacist with at least 3 years of clinical experience.
  • Good understanding of medical terminology and its clinical relevance and application use.
  • Good understanding of clinical paper appraisals.
  • Possess work experience relating to pharmacovigilance concepts in Australia, coupled with knowledge of local and international regulations relating to natural health products.
  • Possess work experience and skill in medical writing.
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. We are committed to connecting every person on earth to the healing power of nature by combining our knowledge of nature and science to deliver quality health solutions to people and their pets everywhere, every day.

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