Global Drug Safety Physician
A top 10 global pharmaceutical company is currently recruiting a Global Drug Safety Physician. This organisation develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally. Based in the company's office in West London, this position offers an exciting opportunity to work with an internationally renowned company and bolster a career in the clinical field.
- Leading or supporting the proactive monitoring and evaluation of all aspects of the safety profile of designated products and ensuring that optimal decisions are made, relating to:
- Signal detection activities
- Safety signal evaluations
- Updates to product labelling documents
- Responses to regulatory agency enquiries
- Product quality issues
- Leading or supporting the management of safety issues through matrix teams across the global organisation and presenting your findings to company governance bodies, including Global Labelling Committee.
- Ensuring that safety documents are written accurately and in a timely manner to meet global compliance and regulatory requirements.
- Providing medical reviews and sign-off for regulatory documents, including Periodic Benefit Risk Evaluation Reports (PBRERs) and Risk Management Plans.
- Working as part of a team, you'll be given full support and training as well as the excellent package you can expect from the company.
Skills and Requirements:
- Medical Degree - MD, MBBS (GMC Eligible). An Advanced Degree in Life Sciences or Pharmacovigilance is also desirable.
- An awareness of international pharmacovigilance requirements (e.g. ICH, European Pharmacovigilance legislation, FDA and CIOMS initiatives) and the drug development and approval process in major countries.
- Knowledge of other relevant disciplines (e.g. statistics, pharmacoepidemiology) pertinent to safety at the population level.
- Prior experience managing multiple strategy formulation and change projects.
- Experience with Pharmacovigilance processes and global Pharmacovigilance regulations.
- Professional certification in Project management desirable.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Kevin Hansberry at +44 207 440 0636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.