Senior Pharmacovigilance Specialist ANZ

• Great Place to Work® Certified - 2024
• Exposure to various pharmacovigilance activities and therapeutic areas
• J&J benefits include: Onsite parking, Gym, Fitness Reimbursement, Volunteer Days, and much more!
• Preferred Location: NSW + flexible work practices 

ABOUT THE COMPANY

At Janssen everything we do is engineered with the patient in mind. It drives us to search for new ideas and innovative healthcare solutions. We embrace challenges and develop treatments that will change the lives of our patients.

We believe in connecting our own expertise and capabilities with those of others, seeking the most creative minds in every field. Together we can find transformational solutions.

At Janssen, we collaborate with the world for the health of everyone in it.

THE OPPORTUNITY
Be part of an exciting and rewarding role where you will lead and partner with Janssen key stakeholders to shape and execute the pharmacovigilance activities for Australia and New Zealand.

You will be responsible to ensure that the Local Operating Company (LOC) safety activities are managed in compliance with local regulations and company policies/procedures at a local, regional, and global level and in accordance with any pharmacovigilance agreements with third party business partners.

Reporting to the Country Safety Team Lead Australia & New Zealand of International Pharmacovigilance, your key focus will be to;

RESPONSIBILITIES

• Collaborate with the local operating company (LOC), regional and global affiliates to enable the fulfillment of regulatory responsibilities (including pharmacovigilance agreement) and meet business objectives.
• Lead and collaborate with cross-functional teams to develop local Risk Management Plans (RMP)/Australia-specific annex (ASA) in compliance with local regulations. Track/oversight of implementation of additional risk minimisation activities and ASA commitments.
• Assess PV impact of company-sponsored Related Research Activities (RRAs) and conduct training on PV requirements to internal stakeholders and external vendors ensuring systematic collection of safety data from company-sponsored RRAs and oversight to ensure PV compliance.
• Review PV Agreements (PVAs) and other contracts with external vendors.
• Support PV regulatory requirements monitoring, review, and implementation.
• Review and implement Clinical Trials Safety Monitoring Plan (SMP)
• Collaborate and support Case Management Team

• Tertiary qualification in pharmacy, life science or pharmaceutical degree
• Pharmacovigilance experience in the pharmaceutical industry
• Solid stakeholder management skills and achieving business deliverables 
• Strong understanding of the Australian and New Zealand pharmacovigilance requirements and global aspects of drug safety
• Understanding of Global Medical Safety database systems
• Experience in case management and PSP vendor PV compliance oversight, PVA, SMP, and development of RMP/ASA is preferred.
• Excellent verbal and written communication skills, presentation skills

COMPANY CULTURE 
You will be rewarded through a competitive remuneration package along with continuous training, support and award-winning leadership development programs. 

Being part of Johnson & Johnson can change everything, including YOU:

Janssen is driven by dedication to product innovation, customer focus, and organisational excellence. From research to real-life solutions, Janssen has a long track record in developing and marketing treatments that make a real difference.