Senior Manager Risk Management
- Interim/Contract
- Medical, Medical Compliance
This vacancy has now expired. Please see similar roles below...
Hobson Prior are recruiting for a Senior Manager Risk Management to join a research-based biopharmaceutical company on a contract basis in Cambridge. Our client is very patient-focused, whose scientific research has benefitted hundreds of thousands of people by ensuring medications are available to those who could otherwise not afford them.
Please note that to be considered for this role you must have the right to work in this location.
Job Responsibilities:
- Signal detection and authorship of signal work-up documents in collaboration with Medical Safety Science Medical Evaluation team member.
- Authorship of Company Core Data Sheet sections and associated supporting documentation.
- Authorship of aggregate safety reports.
- Authorship of risk management plans.
- Authorship of responses to regulatory agency safety enquiries.
- Contributes to safety analyses in Regulatory submissions.
- Reviews global literature for identification of 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 in collaboration with a MSS-ME team member Essential Duties and Job Functions.
- 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.
- Begins to establish recognition within the job family as a technical expert.
- Familiar with searching drug safety and literature databases for relevant information.
- Contributes to safety committee meetings.
- Participates as a member of various cross-functional teams, including participation on Clinical Development Teams involving interaction with Medical Monitors, Clinical Scientists, Clinical Operations, and other Medical Affairs personnel.
- May act as a mentor to employees with less experience.
- May lead projects with supervision.
Requirements:
- Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field or a relevant scientific/technical discipline.
- 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.
Apply now:
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
Can’t find what you’re looking for?
We don’t advertise all of our vacancies online. Register with us and we can let you know the next time your perfect role becomes available, or want to discuss your options with a specialist?
Register