Description:
DescriptionPurpose 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 position will require strong leadership, strategic thinking, and excellent communication skills to drive project success and support the Blackmores strategic goals.
This is a hybrid role, where 2 days from home and 3 days in an office in Sydney (preferably in Warriewood)
Responsibilities include:
Medical responsibilities:
- 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.
Product Safety (Pharmacovigilance) responsibilities:
- To 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 an
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.