Work Opportunity as a Senior Drug Safety Associate at Avance Clinical – Apply Now

Avance Clinical, a well-known clinical research company, is thrilled to share that a Senior Drug Safety Associate position is open. This might be the best option for you if you’re an experienced professional looking for a fast-paced work atmosphere and an opportunity to help shape the future of clinical research!

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.

Role Title: Senior Drug Safety Associate
Location: Bengaluru

Qualifications, Skills and Experience
1. Ordinary Degree in an appropriate/related discipline.
2. Minimum of 8 years’ experience in a safety/pharmacovigilance role or relevant combination of pharmaceutical/CRO industry experience and qualifications.
3. Minimum of 8-10 years’ experience in pharmaceutical industry/CRO working in a GCP environment.
4. Formal and current ICH GCP training.
5. Thorough knowledge of Australian regulatory and EC Clinical trial safety reporting requirements.
6. Sound knowledge of FDA and EMA regulatory and EC Clinical trial safety reporting requirements
7. Sound knowledge of MedDRA and WHO Drug coding.
8. Ability to communicate at a high level with clients, senior management and other stakeholders.

Why should you join Avance Clinical?
1. 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.
2. 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.

Broad Purpose
The Senior Drug Safety Specialist 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
1. Configuration of study specific safety databases in accordance with Avance SOPs.
2. Maintain a project specific safety database/dataset (where Avance Clinical holds the safety database).
3. Create, modify and/or review study specific SRPs as required per project in accordance with the CSP and Client/Avance Clinical contractual arrangements.
4. Prepare ICSR reporting forms and completion guidelines for the Investigational Sites and liaise with the CPMs and CRAs to ensure timely distribution of the approved forms and guidelines to the sites
5. Participate in Study “Kick-Off” meetings with study project staff as required.
6. Autonomously act as Lead Safety Officer and maintain oversight on regulatory compliance and status of safety-related services for assigned projects.
7. ICSR processing – Ensure timely reporting, tracking, filing and distribution of SAE, EIU, SUSAR, and/or other safety reports (as required) to applicable parties including Regulatory Authorities (RAs), Ethics Committees (ECs), Sponsors/Clients and Investigators.
8. Perform reconciliation of SAE receipt and Regulatory reporting with Sponsors/Clients as outlined in the Study Specific SRP.
9. Liaise with Data Management (DM) for reconciliation of information provided on SAE reports with the study Adverse Event database and entering of single cases into the SAE and EIU Database where applicable.
10. Ensure up-to-date knowledge of applicable regulatory safety requirements associated with relevant countries as required on a per project basis.

What we offer
1. Stimulating work
2. Project diversity
3. An intellectual challenge
4. An agile & flexible workplace
5. Opportunity to progress
6. Stability
7. Sense of community
8. A leadership team that are working together on a common goal
9. Flexible work options
10. Great tools / tech to do your job
11. 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 / US / Indian working rights to be considered

Alternatively, you could e mail your CV to ramya.yadehalli@avancecro.com

At Avance difference is encouraged, its celebrated and it’s something we strive for. We empower cultural, disability, LGBTI+, and gender equality.

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