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Medical Safety Physician - Ireland  

Company managed [?] Still accepting applications

Posted on : 26 April 2017

Project Description

Description:
As a member of the Pharmacovigilance, Quality & Safety department, the Director, Medical Safety Physician will be responsible for medical review of individual case safety reports as well as medical review of  aggregate safety data. The Drug Safety Physician may also contribute to safety surveillance activities, safety process and convention development, and attend various safety related meetings. 


Essential Functions 
  • Performs medical review of individual case safety reports (clinical and spontaneous), including coding, seriousness, expectedness and Company causality assessment for a assigned cases.
  • Provides appropriate medical interpretation and consistency to adverse event case assessment.
  • Performs aggregate safety data review on an ad hoc basis in order to support department initiatives in process improvement and regulatory compliance.
  • Provides pharmacovigilance and drug safety support for internal and external customers
  • Maintains knowledge of global regulatory authority regulations (especially FDA and EMEA) and apply appropriately to all activities.
  • Contributes to the training, leadership and continuing education for all departmental staff


Key Responsibilities
  • Performs medical review of individual case safety reports (clinical and spontaneous), including coding, seriousness, expectedness and company causality assessments.
  • Provides appropriate medical interpretation and consistency to adverse event case assessment.
  • Provides medical contribution and performs medical review of aggregate reports
  • Provides medical contribution and performs medical review of responses to regulatory authorities
  • Provides medical input into signal management activities (detection, validation, assessment) for assigned products
  • Performs aggregate safety data review on an ad hoc basis in order to support safety evaluations
  • Provides expert input into function/departmental initiatives as part of process improvements and ensuring regulatory compliance.
  • Participates in due diligence activities as appropriate.
  • Provides pharmacovigilance and drug safety support for internal and external customers
  • Maintains knowledge of international regulatory authority regulations (especially FDA and EU/EEA) and apply appropriately to all activities.
  • Participates in departmental activities to ensure internal audit and regulatory inspection readiness
  • Contributes to the training, leadership and continuing education for all departmental staff


Required Knowledge, Skills, and Abilities 
  • At least 8+years of experience post-residency, with at least 2 years of clinical experience and 5 years of experience  in pharmacovigilance at a pharmaceutical/biotechnology company.
  • Exposure to working relationship with the FDA and other regulatory authorities is preferred
  • Knowledge and understanding of national and international regulatory guidelines and drug safety practices
  • Strong knowledge of individual adverse event case report processing, triage and medical review
  • Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice
  • Experience with safety databases (Argus preferred) and safety coding dictionaries (MedDRA, WHODRUG)
  • Excellent oral and written communication skills
  • Excellent teamwork and interpersonal skills are required

Required/Preferred Education and Licenses 
  • M.D. degree required
  • Medical licensure in at least one state preferred 
  • Board certification in a specialty appropriate to the products of our company  preferred

Description of Physical Demands 
  • Occasional mobility within office environment.
  • Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment 
  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.



Equal Opportunity:

Our company is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.