Area Safety Lead, Anz

3 days ago

Ultimo, Australia Johnson & Johnson Full time

Description

Kenvue is currently recruiting for:
**Area Safety Lead (6mth MAT Leave Cover)**

**Responsible as the main point of contact for pharmacovigilance matters with local health authorities across Australia and New Zealand.**

This position reports into the ASPAC Regional Head and is based at Ultimo, Sydney.

**Who We Are**

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson’s and BAND-AID® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you Join us in shaping our future-and yours.

**What You Will Do**

The Area Safety Lead is responsible for:

- Acting as the nationally nominated contact for Pharmacovigilance in Australia and New Zealand assuming the pharmacovigilance role as defined by national law
- Oversight of vendor resources and function as a delegate for the Regional Safety Head as required
- Maintaining oversight of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements and collaborating with global teams to implement process changes

Key Responsibilities
- Ensure that day-to-day Pharmacovigilance functions are performed satisfactorily, and that optimal regulatory compliance is maintained at the Local Operating Company level.
- Collaborate with the Qualified Person of Pharmacovigilance (QPPV) offices as required.
- Escalate compliance issues in a timely manner to Regional Safety Head to ensure appropriate mitigation is implemented.
- Advise the local business on the Pharmacovigilance impact of local organized data collection programs.
- Recording self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPA (Corrective and Preventative Action).
- Identify periods of high Pharmacovigilance workload and manage Pharmacovigilance resource appropriately to address them.
- Maintain oversight on day-to-day Adverse Event inbound and outbound reporting as applicable.
- Supporting in the responses to safety-related health authority queries in the territory
- Ensure awareness of changes in regulations which may have an impact on vigilance activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups of any changes to local laws and regulations regarding safety.
- Accountable for the provision of information to the global teams for local activities compliance with individual cases and periodic safety reporting, implementing of risk management plans, and key performance indicators related to overseeing local implementation of any other specific risk management activities.
- Ensure proper documented training on safety reporting responsibilities of Local Operating Company personnel and maintenance of awareness of safety reporting in general.
- Ensure implementation of the local procedures where applicable and assessing the impact of changes for the global procedure to local procedures
- Lead local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable.

**Qualifications**:
**What We Are Looking For**

Required Qualifications
- Health Care Science Professional (preferably Physician or Pharmacist).
- 6-8 years of relevant experience.
- Pharmaceutical industry experience including product vigilance responsibility role.
- Experience as line manager and vendor resource oversight
- Desired Qualifications
- Ability to organize workflow activities and manage multiple critical issues
- Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology
- Expert knowledge of global, regional, and local procedural documents as applicable
- Computer literate with knowledge of relevant IT safety systems
- Excellent verbal and written communication skills
- Ability to negotiate and communicate with internal and external customers
- Ability to establish and maintain open relationships within the organization and with authorities
- Demonstrable knowledge of all local requirements and of global aspects of product safety.

**What’s In It For You**
- Competitive Benefit Package
- Benefits include Onsite Parking, Flexible Working, Health and Wellness Reimbursement, Volun

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