Medical & Pharmacovigilance Associate

4 months ago

Surry Hills, Australia Blackmores Group Full time

**Purpose of role**:
As Australia’s Most Trusted Manufacturer of natural health products for the past 15 years, 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 business that places wellbeing and workplace flexibility at the heart of our culture We are excited to offer the role of a Medical and Pharmacovigilance Associate

This role will report to the Director of Pharmacovigilance & Product Quality. The main purpose of this role is to 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.

We are hiring for **two (2) roles **on a permanent basis. This role is uniquely positioned to cover both product safety and medical responsibilities. The role will be required to work in office 3 days a week.

**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 with at least 3 days of work in office
- 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 programCompensation package that includes a base salary, superannuation, profit sharing

**What will you do?**

**Product Safety (Pharmacovigilance) 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.
- 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 and PV section of the QMS system.
- Perform internal PV audits as required.

**Medical responsibilities**:

- 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.

**Who are you?**
- Possessing at least 3 years of clinical experience will be beneficial.
- Good understanding of clinical paper appraisals.
- Possess work experience relating to pharmacovigilance concepts in Australia, coupled with knowledge of local and international regulations relating to natural health products.Possess work experience and skill in medical writing.

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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