AddressKenvue 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 , 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. For more information, .
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.
