£50 - 60 per hour
11 months ago
My client, a leading Nordic pharmaceutical company that specialise in oncology are looking for a PV specialist to support them for an initial 6 months.
Title: PV specialist
Location: Home based
- Ensure timely safety reporting to regulatory authorities, ethics committees/independent review boards and investigators (expedited including cross-reporting and periodic) in clinical trials
- Ensure documented medical review of all serious adverse events in clinical trials
- Ensure close collaboration and communication with PV vendors on outsourced PV tasks
- Ensure monthly compliance reports are received from PV vendors, reviewed by PV and any compliance issues are reported to QA
- Report and follow-up on PV deviations
- Ensure compliance with PV SOPs
- Review and update PV SOPs
- Support PV Physician in preparation of DSURs (Development Safety Update Reports) and the safety section of Investigator Brochures
- Provide safety data to PV physician for signal detection review
Looking but this isn’t the right position for you?
If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to firstname.lastname@example.org or call 0203 589 9282 for a confidential discussion about potential opportunities.
NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?
Catalyst Life Sciences offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.
Catalyst Life Sciences
Catalyst Life Sciences are a global recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets;
- Pharmacovigilance/Drug Safety
- Regulatory Affairs
- Quality Assurance
- Quality Control
- Medical Information
- Medical Writers
- Medical Affairs
- Clinical Trials
- Clinical Research
- Project Management
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I personally specialise in recruiting QA and validation professionals for roles globally so please do get in touch should you be considering new roles, or looking to fill ones at your current company!