A leading US biopharmaceutical organisation with a solid commercial portfolio of life-saving drugs within a number of therapy areas have a new Asssociate Manager job opportunity at their offices in Cambridge, UK. The company has a growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents.
- Signal detection and authorship of signal work-up documents in collaboration with a safety physician.
- Authorship of CCDS sections and associated supporting documentation.
- Authorship of aggregate safety reports (e.g., PSURs).
- Authorship of risk management plans.
- Authorship of responses to regulatory agency safety enquiries.
- Contributes to safety analyses in Regulatory submissions (e.g., MAAs, NDAs).
- Reviews global literature for identification of individual case safety reports and potential safety concerns.
- Performs safety review of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies.
- Reviews standard reference documents and develops listedness/expectedness tables in collaboration with a safety physician.
- Work is performed under close supervision following established procedures.
- Develops basic knowledge of pharmacovigilance, regulations, aggregate safety reports, risk management plans, signal detection, clinical trials, and clinical development.
- Demonstrates ability to present results and findings and discuss processes in formal settings, including Clinical Development Team, Study Management Team, and Product Safety Committee meetings.
- Shows ability to effectively collaborate with cross-functional staff.
- Communicates effectively to ensure relevant parties are fully informed and knowledgeable of project activities and their status.
Skills and Requirements:
- Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline (e.g. biology, chemistry, or neuroscience).
- Some experience (2+ years) in the pharmaceutical industry, at a regulatory agency, or in clinical research is preferred.
- Demonstrates a good level of competency in verbal and written communication, including Microsoft Excel, Office, Word, and PowerPoint.
- Demonstrates good analytical thinking skills, attention to detail, teamwork, initiative, and basic project management skills; maintains confidentiality; maintains meticulous attention to project deadlines.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 4400 636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.