Medical Product Specialist - Prestigious local HQ company

A fantastic opportunity has arisen for a Senior Pharmacovigilance Specialist to work with a well known global Pharma client within their Australian affiliate office based in Melbourne.

* Opportunity to step up from a Medical Information role

* Interesting product portfolio

* Cross functional role

Our client is looking to recruit on a permanent basis a Senior Pharmacovigilance Specialist and/ or a Pharmacovigilance Specialist to work with a established Safety team and reporting through to a highly experienced Drug Safety Manager. The size and nature of the group allows for this role to have so much more scope and breadth than a typical local safety opportunity.

THE ROLE:

Carry out day to day Adverse event and Serious event processing (Clinical and post approval safety)

Fulfil regulatory reporting requirements to the TGA and Ethics Committees

To support the Manager and provide pharmacovigilance advice and support to the local Australian affiliate office.

•Act as deputy Pharmacovigilance contact in the Manager's absence.

•Deputise as point of contact for communication with Regulatory Authorities on drug safety issues.

•Review and reporting of spontaneous and clinical trial adverse events internally to Corporate Global Pharmacovigilance using global Arisg database

•Investigation and follow up of adverse event reports.

•Training of internal personnel on relevant drug safety responsibilities.

•Support the Med Info Department on the provision of safety information.

•Review and submit PSURs and ASRs.

•Review/develop local SOPs.

•Assist with review of quality complaints for medical issues/trends.

•Ensure compliance with statutory obligations in respect of the above

This position, Medical Product Specialist - Prestigious local HQ company, was posted on January 22, 2010. The job is located in Melbourne. Since this job has been published, it has been viewed 35 times.