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Lead Safety Medical Director

Reference Number: 2883
Location: Southeast

Our client is a leading international specialty biopharmaceutical company.  They have asked us to assist them in their search for a Lead Safety Medical Director.

The Lead Safety Medical Director is responsible for ensuring that the benefit risk assessment of the product is current and that changes to the assessment are followed by appropriate discussion and actions, per the company’s governance principles.  The incumbent will ensure patient safety of company products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of PV Assessment activities through product development, product maintenance and life cycle management.  This position is responsible for all activities related to pharmacovigilance, clinical safety, risk management and signal detection, and for reporting back to the Patient Safety organization relevant information regarding status, issues, challenges etc.  The incumbent will be accountable to lead in a matrix structure the Benefit/Risk activities that ensure the timely signal detection, risk management/mitigation plans, safety analyses in aggregate reports and the scientific review of safety related information, ensuring the timeliness and accuracy of the safety information in responses to Health Authorities, product labeling and investigator brochures.

Major tasks and responsibilities will include:

  • Ensures adequate representation for all activities related to pharmacovigilance, clinical safety, risk management and signal detection.
  • Ensures PVU issues and challenges, including benefit/risk changes, are known by the Patient Safety organization.
  • Leads the effort within Patient Safety to ensure Patient Value Unit (PVU) deliverables are met.
  • Ensures adequate representation of different functions (not limited to safety) has been identified to contribute to the benefit risk assessment, Safety Risk Management Strategy (SRMS) and other safety driven documents in collaboration with the line managers.
  • Leads the cross functional effort within Patient Safety and when appropriate with outside contractors to ensure Patient Safety deliverables are met.
  • Ensures that the Benefit Risk Assessment, SRMS and other safety driven documents are current , aligned and that changes to the assessment are followed by appropriate actions to be proposed to the PVU.
  • Leads interactions between the BRT and QPPV and BRB ensuring good communication that is both appropriate and timely.
  • Is accountable to the PVU that reporting requirements are met.
  • Ensures that the Case Processing teams are aware of the project specific issues (product, disease or protocol related).
  • Ensures compliance with global regulations and ICH guidelines regarding the preparation of required regulatory expedited and periodic reports, in collaboration with other Patient Safety teams.
  • Prepares, as required, ensures review, and approval of product safety information in all ad hoc documents or regulatory-required periodic reports requiring medical review and interpretation, including providing medical opinion on all relevant documents prior to submission to regulatory authorities, journals and external documents prior to submission to regulatory authorities, journals and external meetings, and providing medical input to protocols and end-of-study reports.
  • Leads scientists and physicians in the assessment and writing of medical sections in periodic reports, ad-hoc safety analyses, responses to regulatory authorities and clinical study documents.
  • Responsibility for the combined (clinical study and post marketing sources) Safety Signal Detection process.
  • Liaises with LSOs on responses to local authorities.
  • Reviews and approves all aggregate reports for assigned products.
  • Approves responses to questions from competent Authorities.
  • Facilitates the production and maintenance of RMPs and REMS.
  • Ensures that designated RMP team members document the effectiveness of risk minimization activities, as described in the RMP.
  • Ensures timely reporting to Health Authorities on progress, execution and effectiveness of commitments as required by Health Authorities.
  • Analysis of unlisted (unlabeled) serious and non-serious reactions.
  • Prepares, as required, reviews, and approves product safety information in all ad hoc documents or regulatory-required periodic reports requiring medical review and interpretation, including providing medical opinion on all relevant documents prior to submission to regulatory authorities.
  • Takes part in the review of inputting to investigator brochure content, expert reports, and pooled study data.
  • Provides Patient Safety input into the setting up and updating of safety data exchange agreements.

We seek candidates with the following qualifications:

  • Five years of pharmaceutical industry experience with a proven and successful track record in scientific and project team leadership.
  • Proven track record of having led a multidisciplinary biologic product, safety or benefit risk team.
  • Understanding of the global pharmacovigilance and safety requirements from non-clinical development through the registration process and onto the market.
  • Good knowledge of pharmacovigilance relevant regulations.
  • Proven evidence of effective delivery of high quality documents.
  • Knowledge of relevant concepts in data management and systems, epidemiology and statistics.
  • Can act without oversight in most circumstances and is able to provide key input to difficult or sensitive project.
  • Can identify risks and propose corrective actions in complex and critical situations.
  • Ability to lead a multifunctional team.
  • Basic project management skills to allow management and delivery of multiple complex deliverables within tight timelines.
  • The technical skills and capabilities to author/contribute to large complex documents within document management systems.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2883. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.