Medical & Pharmacovigilance Associate

7 days ago

Surry Hills, New South Wales, Australia Blackmores Group Full time

Medical & Pharmacovigilance Associate:

Purpose of role:

This role champion activities related to product safety and pharmacovigilance for Blackmores Group entities. Ensuring Blackmores comply to our Product Safety and Pharmacovigilance obligations for all market requirements.

This role reports to a Head of Regulatory Compliance & New Markets and is expected to work in a hybrid arrangement of working 1 day from home and 4 days from office - either Surry Hills or Warriewood.

Responsibilities include:

  • To draft, clinically assess, implement, and maintain Ingredient Safety Assessments (ISA) and Product Safety Assessments (PSA) for products across Blackmores Group (BKL).
  • To draft and provide recommendations for Product Risk Assessments.
  • Review and approve documents for the product labels approval process.
  • Implement and maintain the Product Safety Policy, Standard, and Standard Operating Procedure.
  • Be the subject matter expert for all product safety related enquiries for products in the Blackmores Group.
  • Respond, in a timely manner, to internal and external stakeholder medical enquiries related to product safety with a patient-centric focus, ensuring compliance to industry codes/regulations/ethical business practices.
  • Perform internal ISA and PSA audits as required.

Who are you?

  • Education background in pharmacy and is currently a registered pharmacist.
  • Minimum 3 years clinical experience (an advantage) or related work experience in medical product safety or pharmacovigilance.
  • Solid understanding of medical terminology and its clinical relevance/application. Solid understanding of clinical paper appraisals.
  • Working knowledge of pharmacovigilance concepts in Australia an advantage.
  • Working knowledge of national and international regulations an advantage.
  • Experience and skill with medical writing an advantage.

What we offer:

  • Great benefits to support your health and wellbeing, including access to free and discounted products and additional leave for your wellbeing
  • Mental health support for you and your family through our Sonder assistance program
  • Opportunities to support your local community through paid community leave

Agencies please note: this recruitment assignment is being managed directly by Blackmores Talent Acquisition team. We will reach out to our preferred agency partners if required. Your respect for this process is appreciated.

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