Senior Pharmacovigilance Specialist

Job Description

Senior Pharmacovigilance Specialist

• Looking for a new and exciting challenge as a Senior Pharmacovigilance Specialist whereby you can utilise your existing pharmacovigilance skills across an exceptionally broad array of products and species?

• Permanent Full-time position with competitive renumeration and benefits
• Location: Sydney, Australia
• Hybrid, work from home and office environment, with a dedicated and welcoming team
• Join a growing, yet already successful animal health company with a cutting-edge product portfolio
• Upskill and grow within a large organisation in an area you’re passionate about, whilst being fully supported and encouraged
• Join a trusted Global leading Animal Health organisation

In addition to the day-to-day PV Team Member Adverse Event reporting and compliance responsibilities, the Senior PV Team Member is required to take on a leadership role across certain aspects of PV within the ANZ Animal Health business. They will support the ANZ PV Team Leader and ANZ RA & PV Manager and will be accountable for driving from initiation to completion more significant and complex PV related tasks.

The Senior PV Team Member role sits within the Regulatory Affairs department of the Animal Health organization and reports to the ANZ Pharmacovigilance Team Leader.

What You Will Do

Responsibilities include, however not limited to:

• Support the ANZ PV Team Leader and ANZ RA & PV Manager to ensure, within a rapidly growing business, that PV requirements are met for a broad array of products (pharmaceuticals, biologicals, devices and other unique product types).
• Consider global and local regulatory authority and industry PV policies and trends with potential to impact ANZ and ensure these developments are incorporated into local pharmacovigilance activities.
• Apply commercial experience and PV knowledge to manage critical projects to ensure internal and external PV requirements are met across a spectrum of different situations e.g. business agreements, product acquisition, services provided by external third parties, in licensing/ out licensing agreements, varying social media scenarios, animal studies, market research, regulatory support.
• Collaborate with global pharmacovigilance colleagues on issues with global implications.
• Liaise with local regulatory authorities, as needed, for non-routine complex pharmacovigilance matters.
• Work with PV team members to ensure ANZ business PV needs are identified and the necessary training materials are compiled, and the training implemented.
• Support the ANZ PV Team Leader to provide ongoing oversight to ensure the PV case load and routine PV tasks are managed across the team and compliance is maintained Play a key role in PV audit activities.

Internal Adverse Event Reporting and Compliance

• Maintain a current local and Global PV training status to DPOC (designated point of contact) level.
• Assist with entry of local PV cases into PV Works in accordance with local and global PV procedures and timelines.
• Ensure that internal compliance is maintained for Adverse Event (AE) reporting by ensuring all AE reports are submitted to the Global Pharmacovigilance Team within the required timeline.
• Upon direction of ANZ PV Team Leader (or Regulatory Affairs and PV Manager) you will be required to act as DPOC and/or Back up DPOC for the Australian or New Zealand Animal Health business.

External Adverse Event Reporting and Compliance

• Ensure that all relevant adverse events are reported to the APVMA and the ACVM within the stipulated time frame.
• Ensure submission of the periodic Adverse Event listing to the AERP as per guidelines provided by the APVMA.

What You Must have

• Tertiary qualifications in Veterinary Science
• Extensive prior experience in a regulatory/PV Animal Health environment
• Sound knowledge of animal health - both production and companion animal
• Ability to absorb, analyse and disseminate (oral and written) technical and scientific related information
• Demonstrated logical approach to problem solving and ability to solve complex problems.
• Understanding of quality systems
• Ability to consider colleagues and work well within a team – communicate and collaborate effectively both within the PV Team and across departments to achieve common business goals
• An understanding of animal studies for both biological and pharmaceutical products is preferred
• Track record of rolling out effective PV related training programs
• Leadership/ management experience is preferred
• Strong ability to manage time and prioritise workloads so as to ensure commercial outcomes, PV requirements and related regulatory requirements are met within a timely manner
• Self-starter with initiative, who works well with minimal supervision
• Ability to work under pressure to meet deadlines
• Ability to make sound decisions on a day-to-day basis.
• Display a sound, pragmatic and prompt decision making capability when dealing with key stakeholders.
• Excellent organization skills and attention to detail.

What You Can Expect

• Work autonomously whilst being supported, encouraged and being part of a trusted Global Leading Animal Health organisation
• Exposure to upskill and develop in your role
• Flexibility and opening doors to other opportunities
• Joining a collaborative team of likeminded individuals

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Current Contingent Workers apply HERE

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