Medical & Pharmacovigilance Associate

As a purpose-led, performance-driven organisation, Blackmores Group strives to create remarkable employee experiences through supporting a diverse and inclusive culture, creating leadership that inspires high performance, and providing everyone with opportunities to achieve their professional, personal and wellbeing goals supported by our flexible work practices and family friendly policies.

Blackmores Group operates in 11 markets, with headquarters in Sydney, an international state-of-the-art manufacturing facility in Braeside, Victoria and additional offices in South East Asia and China.

This is a hybrid role, where 2 days from home and 3 days in an office in Sydney - we have offices in Surry Hills, just beside the Central train station or Warriewood in the northern beaches - with carparking or public transport options available.

**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 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.

**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.
- 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.
- 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.
- 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
- Profit share, we all work together to make profit so we all get a share
- Mental health support for you and your family through our Sonder assistance programOpportunities 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._