Senior Drug Safety Specialist
Who are we? We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field. Why should you join Avance Clinical? We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success. We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future. The role Due to continued growth, we are seeking applications for a Senior Drug Safety Specialist. This role is responsible for the provision of Drug Safety reporting and management services for assigned projects, ensuring the preparation (or review) of Safety Reporting Plans (SRP), the collection, processing and reporting of safety events and other safety information in accordance with the Clinical Study Protocol (CSP), Avance (or sponsor) Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements. A key part of this role is DSUR preparation so experience in this area is highly advantageous. Qualifications, Skills and Experience • DSUR preparation experience • Ordinary Degree in a life science related area. • Minimum of 4 years’ experience in a safety/pharmacovigilance role or relevant combination of pharmaceutical/CRO industry experience and qualifications. • Minimum of 4 years’ in a GCP environment. • Formal and current ICH GCP training. • Sound knowledge of Australian regulatory and EC Clinical trial safety reporting requirements • Sound knowledge of MedDRA and WHO Drug coding. • Excellent oral and written communications skills including the ability to liaise with clients, prepare reports, plans and procedures. • Excellent organisational skills • Ability to work under pressure in a multi-disciplinary team environment. • Intermediate to advanced MS Word and Excel. What we offer • Stimulating work • Project diversity • An intellectual challenge • An agile & flexible workplace • Opportunity to progress • Stability • Sense of community • A leadership team that are working together on a common goal • Flexible work options • Great tools / tech to do your job • A competitive salary & Benefits What next? As a growing business we’re looking for likeminded people to join us – we hope that’s you. • To join our team please submit your CV & cover letter as one Microsoft Word document • You must have full Australian working rights to be considered At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality. Apply tot his job