Medical & Pharmacovigilance Associate - Natural Health Products
3 weeks ago
Blackmores Group is seeking a highly skilled Medical & Pharmacovigilance Associate to join our team. As a key member of our Pharmacovigilance & Product Quality department, you will be responsible for championing activities related to product safety and pharmacovigilance for Blackmores Group entities.
Key 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.
- To 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 change 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.
- A qualified and registered pharmacist. We are also open to explore for 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.
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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