People and Function leader!
Commercial Eyes has a great opportunity for an experienced Pharmacovigilance professional who is ready to lead a substantial team to deliver a global pharmacovigilance service. This role will lead the Pharmacovigilance function partnering with Medical Information and Medical Communications & Patient Engagement leaders to ensure the delivery of benchmark Medical Services for Industry leading pharmacy and medical devices companies.
To be successful in this role, you will ideally possess…..
- Post graduate qualifications in a scientific discipline such as pharmacy, pharmacology, nursing or drug development.
- 5 years plus industry experience in a Senior Drug Safety role.
- Experience leading a team.
- Previous consulting experience or a strong interest in the practise of consulting.
- Knowledge and experience with PV compliance audits.
- Experience with prescription, listed and complementary medicines, devices and consumer goods.
- Strong experience authoring/preparing Periodic Safety Update Reports, Periodic Benefit Risk Evaluation Reports, and Risk Management Reports (PSURs/PBRERs and RMPs) including risk management and signal detection.
- Detailed knowledge and understanding of EU, FDA, Australian, and New Zealand regulatory requirements for safety reporting and the systems and processes needed to ensure compliance.
- Good knowledge of key overseas regulations relating to pre and post-market drugs, device and consumer goods safety.
- Demonstrated experience managing pharmacovigilance quality management systems.
- Highly developed communication, organisational and problem-solving skills.
- Be part of a well-known and established professional services organisation, that has a strong focus on teamwork and that recognises talent and expertise as one of its biggest assets.
- Work with a broad range of local and international industry leading companies, across a global landscape, developing cutting edge health technologies.
- A competitive salary and a flexible work environment, in an environment that respects life-work balance.
- Interesting and challenging projects to grow and enhance your skills and experience.
- Fabulous cbd location and offices.
To apply, please submit your CV and cover letter to firstname.lastname@example.org
Please contact Lorenza Ricacho on 03 9251 0777 for a confidential discussion or to request a copy of the Position Description