Product Safety 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 Regulatory 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:

• Key personnel to interface and provide technical guidance with other departments on safety matters. 
• To draft and/or provide recommendations for Product Risk Assessments. 
• To draft, clinically assess, implement, and/or maintain Ingredient Safety Assessments (ISA) and Product Safety Assessments (PSA) for products across Blackmores Group (BKL), including drafting a Module 4 dossier section (Safety Section) for markets requiring registration support. 
• To conduct review and approve product labels. 
• To prepare or conduct review on ISA and/or PSA documents. 
• To ensure implementation of Product Safety Policy, and Standard Operating Procedure. 
• To draft and/or prepare ISA, and PSA refresher activities on regular basis or if impacted by CIC changes due to formulation updates.
• To assist in processing and compiling administrative legal paperwork to support regional regulatory teams on their registration activities in overseas markets.
• Coordinate with cross-functional teams to gather technical documents, labelling information, and/or product dossier.

Who are you?

• Education background in pharmacy (an AHPRA qualified is good to have) or nursing is preferred.
• Minimum 3 years clinical experience (an advantage) or related work experience in regulatory or quality scope will be advantageous. 
• Solid understanding of medical terminology and its clinical relevance/application. Solid understanding of clinical paper appraisals.
• Solid understanding of safety attributes and product quality.
• Working knowledge of national and international regulations 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.