Reference: 07205 Job Type: Temporary Date Posted: 25 April 2018
Job Type: Temporary
Date Posted: 25 April 2018
Reasons to be excited about this role
- You'll be joining a leading global pharmaceutical company who are committed to ongoing staff development (through experience and training)
- You'll be working with a team of Drug Safety Specialists who have worked for a range of global pharma leaders
- You'll have the opportunity to take ownership of triaging case reports to kick-off the drug safety process (adverse events / serious adverse event determination)
- This is a growing team and there is a good opportunity to move into a Drug Safety Specialist role within 12 months
Why join this company now?
- The company boasts a healthy balance sheet with zero short term debt
- Recently made two strategic acquisitions to further enhance their overall portfolio
- Sales in current drug portfolio is strong with double-digit across major drugs in 2017 (and projected growth for 2018 being similar)
- Strong long-term pipeline across multiple therapeutic areas
Previous experience in case processing and reporting will be of significant benefit to your application. Having worked for a pharmaceutical company or CRO, you will have undertaken previous roles in drug safety or pharmacovigilance (eg. Drug Safety Associate, Drug Safety Intern, Drug Safety Officer, Drug Safety Advisor, Drug Safety Admin, PV Associate, Pharmacovigilance Officer etc.)
Located on the outskirts of West London, you will be part of a team of Drug Safety Specialists, working on clinical trials and ensuring regulatory reporting compliance.
What will your key responsibilities be?
You'll take ownership of coordinating the receipt of case reports, which includes:
- Retrieve case reports
- Check source doc completeness
- Initiate follow-up if needed & log communication in ARISg
- Perform duplicate search and identify exact duplicate source doc
- Perform initial data entry in ARISg
- Determine if AE / Non-AE
- Identify Non-AE follow-up needs and generate letters and attachments
- Identify PQ complaint and notify Quality Department
- Execute exchange of information (e.g. contractual partners)
You will benefit from joining a leading pharmaceutical organisation who are definitely on the rise; they are due launch a number of new major drugs in the coming years and their EMEA team is expanding rapidly. Whilst working as a contractor, they will treat you very much as an essential resource to the business alongside their permanent team.
Apply today for an informal conversation to discuss your career path and how our client could progress you forward in the direction you want to take!
Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.
Drug safety, pharmacovigilance, clinical trials, FDA, EMA, ICH guidelines, PV
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*Terms and conditions apply
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