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Associate Director Signal Management

  • Job type: Permanent
  • Location: Boston, Massachusetts
  • Salary: Negotiable
  • Job reference: 178331/003_1531503839
  • Sector: Safety, EPM Scientific
  • Date posted: 13/07/2018

Associate Director Signal Management

  • Associate Director Signal Management

  • Greater Boston area

A pharmaceutical leader that focuses on developing and manufacturing world-class innovative medicines are currently seeking a Associate Director Signal Management as their company is rapidly expanding! This 10 ten global pharma company has received recognition for their overall success and is looking to increase headcount within the Pharmacovigilance department. Now is a pivotal time to get in with this group as the Associate Director Signal Management will have the ability to lead and impact their robust pipeline of promising new medicines.

The Associate Director Signal Management will have the following responsibilities:

  • Ensures signal detection, evaluation and management processes meet highest standards by working cross functionally and leading the development of required processes (eg with Global Regulatory Affairs, Data Sciences).

  • Ensures that Signal Management processes and activities are compliant with EU regulations and EU regulatory authority and inspectors' expectations.

  • Represents Pharmacovigilance externally at a global level as an authoritative expert on signal detection processes.

  • Leads training for GPSE and other relevant functions on signal detection processes to ensure training and compliance with processes are maintained.

  • Leads interactions with other GPSE functions including EU QPPV and Global Medical Safety to ensure processes are regularly updated and are fit for purpose.

  • Leads interactions and oversight of signal management activities conducted by any vendor.

  • Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal GPSE stakeholders.

  • Leads interactions with other relevant functional areas both within and outside of GPSE to ensure standards are maintained.

  • Represents the pharmacovigilance department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required.

  • Designs and delivers relevant training as appropriate.

  • Provides mentorship and guidance for junior/new pharmacovigilance scientists and others as appropriate.

  • Conduct project activities for designated processes.

  • Any other tasks assigned by manager to assist in related departmental activities.

The ideal candidate will have the following skill set:

  • Health care background or life science degree

  • Bachelors required; degree in life sciences preferred

  • Excellent document creation skills

  • In depth knowledge of clinical trial methodology, pharmacovigilance regulations, signal detection and risk/benefit analysis

  • Ability to review, analyze, interpret and present complex data to a high standard

  • Global player in a global PV organization