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. Those in our industry know we’re experts in our field. We’ve won numerous industry accolades & have completed over 500 studies over the last 5 years. We’ve grown every year since 2019 & have doubled in size over the last 2 years… we’ve a positive future ahead of us.
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.
The role
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.
Core Responsibilities Include
Ensure receipt, assessment (initial and follow up), processing and tracking of safety-related events (SAEs, EIU reports or Events of Special Interest) from study sites in accordance with the CSP, applicable regulations, SOPs, study specific SRP and any other specific agreements related to the management of safety information for a clinical trial.
Generate concise and accurate case narratives liaising with the study Medical Monitor and Sponsor Medical Representative(s) as required, in accordance with each study specific SRP and Client/Avance Clinical contractual arrangements.
Create, modify and/or review study specific SRPs as required per project in accordance with the CSP and Client/Avance Clinical contractual arrangements.
Participate in Study “Kick-Off” meetings with study project staff as required.
Autonomously act as Lead Safety Officer and maintain oversight on regulatory compliance and status of safety-related services for assigned projects.
Ensure timely reporting, tracking, filing and distribution
Qualifications, Skills And Experience
Ordinary Degree in a life science related discipline.
Minimum of 2 years’ experience in a safety / pharmacovigilance role or relevant combination of pharmaceutical / CRO industry experience and qualifications.
Minimum of 4 years’ experience in pharmaceutical industry / CRO working in a GCP environment.
Experience in Literature review.
Formal and current ICH GCP training.
DSUR experience advantageous.
Sound knowledge of Australian regulatory and EC Clinical trial safety reporting requirements
Sound knowledge of MedDRA and WHO Drug coding.
Ability to communicate at a high level with clients, senior management and other stakeholders.
Excellent oral and written communications skills including the ability to liaise with clients, prepare reports, plans and procedures.
Excellent organisational skills with the ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate several tasks simultaneously.
Ability to work under pressure in a multi-disciplinary team environment.
Intermediate to advanced MS Word and Excel.
Prior experience working within a safety / pharmacovigilance database (desirable)
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 & an extra days holiday for your birthday!
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.
Drug Safety Specialist / Pharmacovigilance / CRO / Pharmaceutical / PV / PhV / Literature review / GCP / Australia / Adelaide / Melbourne / Sydney / Brisbane /

Work arrangement
Yes