Medical & Pharmacovigilance Associate - Product Safety Specialist

2 weeks ago

Council of the City of Sydney, Australia Blackmores Group 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
  • Product Safety (Pharmacovigilance) Responsibilities:
    • Receive, enter, investigate, clinically assess, and draft case narratives on adverse product experiences for the Blackmores Group.
    • Determine and perform case follow-up with reporter/patient/HCP to obtain specific case information to facilitate appropriate clinical assessment of serious adverse reactions.
    • Ensure PV cases are reported to Regulators, Data Exchange Partners, and other stakeholders in accordance with regulatory obligations, contractual agreements, and BKL's process and standards.
    • Consistently comply and adhere to BKL's PV Standard and industry/regulatory requirements.
    • Prepare, review, and trend PV reports for internal and external stakeholders as required by the business.
    • Escalate all suspected changes in risk/benefit balance to management immediately for appropriate implementation of risk management plans.
    • Liaise with data exchange partners and other stakeholders for safety data collection and reconciliation within contractual timeline.
    • Perform weekly literature reviews and conduct PV activities as required.
    • Be the subject matter expert for all PV activities.
    • Develop, implement, and document PV training to internal/external stakeholders annually and as required by the business.
    • Manage and maintain the BKL PV program and PV section of the QMS system.
    • Perform internal PV audits as required.
  • Medical Responsibilities:
    • Draft, clinically assess, implement, and maintain Ingredient Safety Assessments (ISA) and Product Safety Assessments (PSA) for products across Blackmores Group (BKL).
    • 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.
    Requirements
    • A qualified and registered pharmacist. We are also open to explore nursing candidates.
    • Possessing at least 3 years of clinical experience will be beneficial.
    • 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 proud Australian heritage, with extensive reach across Asia Pacific. Founded by visionary naturopath Maurice Blackmore in 1932, our vision is to connect 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.

Blackmores Group operates in over 13 markets, with headquarters and a state-of-the-art manufacturing facility in Australia, and offices across South East Asia and China.

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