Clinical Safety Lead

Highly Competitive
  1. Permanent
  2. Product Specialist, Good Pharmacovigilance Practice (GVP)
  3. United Kingdom
Cambridge, Cambridgeshire
Posting date: 22 Aug 2019
DS.KH.25002_1566489997

A rapidly expanding pharmaceutical company is seeking to recruit a Clinical Safety Lead to their office in the UK. The organisation specialises in developing treatments for unmet medical needs. This position offers an exciting opportunity to bring expertise and skill to a highly prestigious organisation and bolster a career in the financial field.

Job Responsibilities:

      • Responsible for strategic clinical safety input and delivery to all asset development activities across a variety of therapeutic areas including oncology.
      • Responsible for clinical safety support for Due Diligence.
      • Responsible for overseeing clinical safety vendor(s).
      • Deliver effective clinical safety strategy for our clinical development pipeline, including successful risk management and signal management activities.
      • Ensure the safety of patients in our clinical development programs through optimal clinical safety monitoring.
      • Provide Clinical Safety expertise to the entire R&D and work closely with Clinical Development on the development of the safety relevant GCP compliant key trial documents such as trial protocol, IB, SMP.
      • Ensure effective and efficient clinical safety support for the evaluation of potential new development opportunities.
      • Vendor oversight for outsourced clinical safety tasks, which include case processing, medical assessment and regulatory reporting.
      • Development of Safety Management Plans.

Skills and Requirements:

      • Medical Doctor with demonstrated industry experience.
      • Demonstrated experience as a safety physician in the Pharmaceutical or CRO industry.
      • Experience with clinical safety in Phase 1 to Phase 3 trials.
      • Experience of working across a global development programme.
      • In depth knowledge of clinical safety regulatory requirements and industry best practices.
      • Demonstrated knowledge and experience of provision of successful Clinical Safety strategy and services.
      • Strong focus on the meeting the needs of our Stakeholders and Customer.
      • 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.

To Apply:

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 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.

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