Hobson Prior are seeking a Senior Risk Manager to work with an extensive organisation that focuses on discovering and advancing innovative therapies against life-limiting diseases.
- Signal detection and writing of signal work-up documents in collaboration with a Medical Safety Science Medical Evaluation (MSS-ME) team members.
- Required to prepare and author formal documentation including; Company Core Data Sheet, aggregate safety reports, risk management plans etc.
- Contribute to safety analyses in Regulatory submissions (e.g., Marketing Authorisation Application (MAAs), New Drug Application (NDAs)).
- Evaluate global literature to identify potential safety concerns.
- Execute safety reviews of clinical trial protocols, investigator brochures, study reports, informed consent forms etc.
- Cooperate with partner companies on safety evaluation for co-licensed products.
- Contribute to safety committee meeting discussions (internal or with partner companies)
- Participates within and potentially lead various cross-functional teams.
- Develop contacts within PVE and across the company.
- Work effectively with MSS-ME, other members of PVE, and colleagues external to PVE.
- Demonstrates proficiency in verbal and written communication.
- Strong project management skills, excellent attention to detail, teamwork and initiative.
- Able to ensure confidentiality when required.
- Maintain meticulous attention to project deadlines.
- Capable of assessing complex data sets and understand the safety/medical implications.
- Demonstrated experience with the responsibilities, deliverables, and skills required for this level.
- Degree or professional qualification in a health science field a relevant scientific/technical discipline is desirable.
- Moderate level (4+ years) of experience in drug safety is preferred.
- Demonstrates proficiency in verbal and written communication,
- Strong capability of using Microsoft Excel, Office, Word, and PowerPoint.
- Strong knowledge of pharmacovigilance, regulations, aggregate safety reports, risk management plans, signal detection, clinical trials, and clinical development.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.