You will be responsible for the receipt, assessment and processing of ICSRs, medical information enquiries and pharmacovigilance literature reviews in compliance with internal and regulatory timelines. You will support the team in the preparation of various internal and regulatory reports for example signal detection reports, aggregate safety reports, compliance reports and the Pharmacovigilance System Master File.
We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, PharmaLex is your career opportunity. PharmaLex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
This is an exciting new position that has been created in our Pharmacovigilance team. If you are a recent graduate or someone looking to start a career in Pharmacovigilance, this would be great opportunity. You can be based from any of our UK offices.
- Responsible for daily and weekly management of mailboxes and associated tracking systems, telephone receipt of ICSRs and medical information enquiries
- Receive and handle medical information enquiries according to project processes, including database entry
- Identification and appropriate processing of safety information received within medical information enquiries
- Creation of Individual Case Safety Reports (ICSRs) deriving from clinical trials, spontaneous reporting systems and the literature, including full safety database entry
- Reporting of ICSRs to competent authorities
- Generation, processing and tracking of ICSR follow-up requests
- Screening scientific literature regarding safety relevant publications e.g. by using the internal search mechanism of Vigilit® and/or by making use of external tools and providers
- To perform quality control tasks such as ICSR processing quality check and other project-specific quality checks
- Assist in the creation of periodic reports, PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports),RMPs (Risk Management Plans) and signal detection reports
- Contribute to the writing and review of quality assurance documents such as Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex pharmacovigilance or medical information projects
- Complete timely training of the above-mentioned QA documents
- Assist in preparation of and participation in internal and external audits/inspections
- Act as a registered EV user on behalf of client companies
- Complete and submit XEVPRMs on behalf of clients
- Contribute to the Pharmacovigilance System Master File (PSMF)
- Professional communication with clients and other stakeholders.
- University degree in Life Science, at least in the upper second class
- Meticulous attention to detail and disciplined working approach is essential
- Adaptability, eagerness to learn proactively and ability to take the initiative is essential
- Prior experience in the pharmaceutical industry, preferably in the field of pharmacovigilance and/or medical information is desirable but not essential
- Excellent written and verbal communication skills
- Confidence to work alone as well as in a team
- Knowledge of pertinent pharmaceutical and clinical practice desirable
- Aim to regularly participate in internal and external professional training.
- 25 days holiday plus bank holiday (increasing to 27 after qualifying service)
- 8% employer pension contribution
- Healthcare/health cash plan
- An opportunity to work within an organisation with a positive work/life balance environment
- Continuous development opportunities through knowledge and experience as well as training
If you are interested in joining our PharmaLex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receiving your CV and a covering letter, explaining how you meet or exceed the specifications for this position, including your salary expectations on-line.
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