Medical & Product Safety Associate

at  Blackmores Group

Surry Hills, New South Wales, Australia -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate08 Jul, 2024Not Specified08 Apr, 2024N/AGood communication skillsNoNo
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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.

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.
  • 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.


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Surry Hills NSW, Australia