Pharmacovigilance Manager (A-PVCP/QPPVA)
Pharmacovigilance Manager (A-PVCP/QPPVA) Bloom Agents is a leading pharmacovigilance specialist company, bringing together... more info
Senior Medical Product Safety & Pharmacovigilance Associate
Salary:
80.00 - 100.00
Posted:
08-03-2025
Category:
Pharmacology, Compliance Regulatory Affairs
Northern Beaches Council,
Job Description
Purpose of role: This role champions activities related to product safety and pharmacovigilance for Blackmores Group entities, ensuring compliance with our Product Safety and Pharmacovigilance obligations for all market requirements. This position requires strong leadership, strategic thinking, and excellent communication skills to drive project success and support Blackmores' strategic goals. This is a hybrid role, with 2 days from home and 3 days in an office in Sydney (preferably in Warriewood). Responsibilities include: 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. Act as the subject matter expert for all product safety-related enquiries for products in the Blackmores Group. Respond promptly to internal and external stakeholder medical enquiries related to product safety, ensuring compliance with industry codes, regulations, and ethical business practices. Perform internal ISA and PSA audits as required. Lead and manage junior associates. Who are you? Educational background in pharmacy and currently a registered pharmacist. Minimum 5 years of clinical experience (an advantage) or related work experience in medical product safety or pharmacovigilance. People management experience is a plus. Solid understanding of medical terminology and its clinical relevance/application, as well as clinical paper appraisals. Working knowledge of pharmacovigilance concepts in Australia is an advantage. Working knowledge of national and international regulations is an advantage. Experience and skill in medical writing is 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. #J-18808-Ljbffr
Job Details
Salary: 80.00 - 100.00
Posted: 08-03-2025
Category: Pharmacology, Compliance Regulatory Affairs
Northern Beaches Council,
