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Senior Medical Director, Medical Safety Evaluation

Reference Number: 3095
Location: IL

Our client is a global, research-based biopharmaceutical company.  They have asked us to assist them in their search for a Senior Medical Director, Medical Safety Evaluation - Risk Management.

Major tasks and responsibilities will include: 

  • Works in collaboration with one or more Senior Medical Director or Medical Director within the Benefit-Risk Management and Innovative Platforms group in Pharmacovigilance and Patient Safety.
  • Defines and defends assigned product’s benefit/risk balance and risk management strategy.
  • Consults with PSTs to develop risk management and PV Plan strategies and implement risk minimization goals.
  • Assures that the organization is compliant with all current regulations (both US and international) pertaining to product safety.
  • Acts as a medical consultant to one or more PSTs to develop strategies to support the risk management activities of multiple products. This includes provision of precedence analysis of existing risk management programs for similar by mechanism of action or product class and for products approved for similar indications.
  • Understands assigned products’ pharmacology and chemistry from a safety perspective, relevant nonclinical toxicology and clinical AE profile.
  • Develops core knowledge of adverse events commonly associated with pharmaceutical agents including long QT syndrome, hepatotoxicity, bone marrow toxicity, drug – drug interactions, nephrotoxicity and immunogenicity and expertise in one of these topics.
  • Collaborates with internal and external relevant parties and develops a comprehensive risk management strategy for each of these topics.
  • Participates in drug safety committees (e.g., signal team meetings, safety committee meetings, etc.) as appropriate.
  • Applies current regulatory guidance for risk minimization to the company’s product safety, RMP/REMS plans, as appropriate. Co-manage Risk Management activities in the development, implementation and maintenance of product-specific premarketing risk management strategies.
  • Works with the Epidemiology staff, applies epidemiological methodology and data to issues of drug safety and risk minimization assessment for assigned products.
  • Works in a collaborative fashion with ADTs and PSTs (within a therapeutic area), to conduct benefit-risk assessments of the company’s products throughout their developmental and post-approval life-cycle. Partners effectively with Statistical colleagues to advise teams on use of quantitative approaches and graphical tools for conducting and communicating BRPAs, when appropriate.
  • Contributes to and leads the efforts in development, implementation, updating and assessment of RMP/REMS for assigned products.
  • Maintains active involvement with related functional areas within the company such as Regulatory Affairs, Clinical Development, Drug Safety, Marketing etc. to provide safety knowledge base for decision-making.

We seek candidates with the following qualifications:

  • MD or DO required.
  • Residency with direct patient management and care in patients in the following areas; Internal Medicine, Oncology, Cardiology, Infectious diseases, is preferred.
  • A minimum of 5 -10 years of experience in the pharmaceutical industry within drug safety, regulatory or clinical research with evidence of experience in leadership, responsibility, and accountability of at least 1 complex and 1 moderate activity drug project (consisting of 2 or more drugs) within a therapeutic area (e.g., cardiovascular, immunology, oncology, etc.) in a multidisciplinary business team consisting of 4-5 members.
  • Experience in Risk management is preferred.

 

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 3095. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.