Job Description
Veterinary Pharmacovigilance Specialist
Looking for a new and exciting challenge as a Pharmacovigilance Specialist within a trusted, leading Global Animal Health organisation whereby you can utilise your existing pharmacovigilance/ technical services/ regulatory affairs skills across an exceptionally broad array of products and species?
* Permanent Full-time Opportunity based in Sydney
* Competitive remuneration and benefits
* Join a market leading, experienced and motivated PV team in a rapidly growing animal health business
* Non-customer facing role
* 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 and pipeline
* Upskill and grow within a large organisation in an area you’re passionate about, whilst being fully supported and encouraged to develop.
The PV Specialist role reports to the ANZ Pharmacovigilance Team Leader and supports the wider PV team to manage all aspects of the Adverse Event reporting process across the local business. The PV Team sits within the Regulatory Affairs department of the Animal Health organization.
What You Will Do
Internal Adverse Event Reporting and Compliance
* Maintain a current local and Global PV (to DPOC level) training status.
* 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. Responsibilities of the DPOC/ Back Up DPOC may include but are not limited to:
* Undertake DPOC related activities as described in Global PV training items.
* Assess and report on any significant Adverse Event cases and trends.
* Prepare and circulate monthly complaint summary to members of the PV Team and Regulatory Affairs.
* Provide quarterly PV Compliance Report to Regulatory Affairs and PV Manager.
* Liaise with the Regulatory Affairs Team to respond to issues raised by the local regulatory authorities (APVMA and ACVM) as a result of their adverse event reporting programs.
* Ensure written local pharmacovigilance procedures are current and reviewed regularly.
* Manage or provide input during PV audits.
* Ensure other departments within the business comply with relevant internal procedures which have PV relatability (e.g. Privacy, In Licensing/ Out Licensing Agreements, Post Authorisation Studies, social media).
* Ensure Global PV training status of “PV Back Ups” is current.
* Oversee training of Animal Health colleagues in GPV procedures which are relevant to their roles (e.g. Post Authorisation Studies, In Licensing/ Out Licensing agreements).
* Champion “Know to Report” training of all Animal Health colleagues.
* Ensure all newly recruited customer facing Animal Health colleagues undergo instructor led PV training.
* Ensure all customer facing Animal Health colleagues undergo regular refresher PV training.
* Maintain a suite of current local PV SOPs which are initiated and reviewed regularly via the local document control process.
* Oversee review of local scientific literature for potential product Adverse Events.
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 annual Adverse Event Summary to the AERP as per guidelines provided by the APVMA.
Quality Complaints
* Assist business entering Quality Complaints into PV works when required.
Support
* Assist Regulatory Affairs and Business Development Managers with product related regulatory tasks as required.
* Provide input into marketing, technical services, R&D and product development projects which have PV relatability (e.g. social media, post authorisation studies, market research).
Training
* Complete all assigned Global and Local PV training.
* Attendance at agreed training courses (identified via performance appraisal and career development discussions with supervisor).
What You Must Have
* A tertiary qualification in Veterinary Science.
* 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.
* Minimum 2 years’ experience in clinical companion animal veterinary practice.
* Knowledge of both livestock and companion animals.
* Industry experience preferred.
* Strong ability to manage time and prioritise workloads 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.
* Understanding of quality systems.
* An understanding of animal studies for both biological and pharmaceutical products is preferred.
* Track record of rolling out effective PV related training programs.
* Excellent written communications skills.
* Competency in MS Office (Word, PowerPoint, Excel).
What You Can Expect
* Work autonomously whilst being supported, encouraged and being part of a trusted, leading Global Animal Health organisation.
* Opportunity to upskill and develop in your role.
* Join 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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