Senior PV and Quality Associate

About the company
This global organisation have a track record of great success in Australia

About the opportunity
The purpose of the role is to ensure the smooth running of the pharmacovigilance functions

Duties

• Assist QA team with logging and responding to complaints/adverse events and medical information queries
• Assist with preparation, review and maintenance of pharmacovigilance agreements
• Perform reconciliation tasks with internal and external partners to ensure accurate reporting of adverse events and product complaints
• Perform Risk Management Plan review and approval in line with QPPVA responsibilities.
• Manage and co-ordinate any requests for internal or external audits from parent company external business partners or TGA for pharmacovigilance activities
• Undertake batch/product release

 

Skills and Experience

• Bachelor’s degree or relevant scientific qualifications
• Understanding and experience of QA
• 3+ years’ experience in the pharmaceutical or biotech industry, preferably within pharmacovigilance
• Excellent communication and interpersonal skills, ability to build trust on all organisational levels and across functions
• Strong organisation and prioritization skills
• Excellent written and verbal communication skills in English
• Ability to work independently and as a team player, working in a cross-functional environment

Culture
Although a large, global company, it can provide a family-like culture and pride then selves in developing and upskilling its staff.

Why this opportunity is right for you
This role is a permanent and full time  opportunity within a good company culture and team environment.