Posted to MedZilla on 8/19/2017


ProClinical

England, Drug Safety Physician DS_KH_13058-MZ


 
 

Our client is a leading biotechnology company that develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. The company is seeking a Drug Safety Physician to join their team in Berkshire, UK.

Job Role:

  • Responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. 
  • Responsible for keeping upper management informed of safety issues and may work with clinical programs as medical advisor. 
  • May represent company Drug Safety and Risk Management at internal and external meetings. The MD can be appointed as the Global Safety Officer for a specific compound / product.

The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through life cycle. The individual who assumes this position will interact with multiple levels of management within the company, external stakeholders in the medical community as well with global regulatory authorities.

Job Responsibilities:

  • Manage safety surveillance for assigned compounds / products
  • Manage collection, in cooperation with a PV scientist, of current data for safety signaling and identify and investigate safety signals.
  • Conduct analysis of safety data.
  • Ensure adequacy of recording, summarizing, and handling of adverse events for investigational and/or marketed products including decisions on seriousness, expectedness, and causality.
  • Provide safety strategic leadership for clinical development programs / program teams: Integrate the safety scientific component to build a strategic framework for clinical development plans.
  • Develop and maintain relationships with program counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.
  • Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities.
  • If applicable, manage Medical Director(s) and Associate Medical Director(s) overseeing their activities for assigned compounds / products.

Education, Skills and Experience:

  • MD, or MD PhD, or MD MPH required; sub specialty training highly desirable
  • Minimum 5 years experience in the pharmaceutical industry or clinical care setting.
  • Preferably has prior experience in clinical development or drug safety.
  • Knowledge of pre- and post- marketing US and EU regulations
  • Knowledge of clinical pharmacology highly desirable.
  • Demonstrated strategic and critical thinking.
  • Excellent communication skills (oral and written) and excellent organizational skills.
  • Capacity and willingness to work effectively across disease areas.
  • The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
  • Demonstrated sense of urgency and accountability for both individual and team-owned work products.
  • Excellent communication skills (oral and written) and excellent organizational skills.
  • Capacity and willingness to work effectively across disease areas.
  • The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
  • Demonstrated ability to work in an entrepreneurial culture

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 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.


Please visit our website at www.proclinical.com

 
 


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