Medical & Product Safety Associate
4 weeks ago
Job Description
As Australia’s most trusted manufacturer of natural health products 15 years running, and one of the Financial Reviews Best Places to Work in 2023, it couldn’t be a better time to join a truly purpose-led brand that has wellbeing and workplace flexibility at the heart of our culture We are excited to offer the role of Medical and Product Safety Associate.
Clinically assess, implement and maintain Product Safety Assessments (PSA) for products across the Blackmores Group. You will ensure we comply to our Product Safety obligations across all our markets. Act as the subject matter expert for all product safety related enquiries and responsible for responding in a timely and efficient manner. Demand an uncompromising focus on the consumer to ensure the safety of our products are at the forefront of everything we do.
What we offer?
- Opportunities to support your local community through paid community leave
- 20 weeks gender neutral paid parental leave
- Flexible working across most of our roles
- A socially responsible work environment, on track to be carbon neutral by 2030
- Great benefits to support your health and wellbeing, including access to discounted products
- Mental health support for you and your family through our Sonder assistance program
Responsibilities include:
- 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.
- Draft, clinically assess, implement and maintain Ingredient Safety Assessments (ISA) and Product Safety Assessments (PSA) for products across Blackmores Group (BKL).
- Administer and maintain the Product Safety Standard.
- 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.
- Ensure PV cases are reported to Regulators, Data Exchange Partners and other stakeholders in accordance to regulatory obligations, contractual agreements, and BKL’s process and standards.
Who are you?
- A registered pharmacist in Australia with experience working in either a retail pharmacy or within industry.
- The ability to clinically assess case reports is strongly required.
- Solid understanding of medical terminology and it’s clinical application, as well as an understanding of clinical paper appraisals.
- Excellent stakeholder and project management are essential, as is the ability to manage tight project deadlines
- Decisive and acts with pace
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.
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.
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