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Medical/Senior Medical Director, Product Safety Team Lead

Reference Number: 3018
Location: Midwest

Our client is a global, research-based biopharmaceutical company.  They have asked us to assist them in their search for a Medical/Senior Medical Director, Product Safety Team Lead.

Major tasks and responsibilities will include:

  • Reviews clinical Individual Case Safety Reports (ICSR) from current and on-going clinical trials and provide sponsor causality assessment.
  • Using applicable coding conventions and regulatory requirements, evaluates all serious adverse event (AE) reports for "seriousness" and "expectedness”, and for medical accuracy and completeness to facilitate regulatory reporting.
  • Ensures that appropriate medical interpretations are applied to adverse event case assessment.
  • Determines the need for additional follow-up information at the time of individual case review for serious adverse event reports.
  • Performs company analysis for expedited ICSR and provide alternative etiology as needed.
  • Ensures timely communication of adverse events of special interest and potential safety signals to PST and GPT.
  • Acts as a primary medical resource to Medical Safety Analyst to provide physician consultations in ICSR related medical issues.
  • Supports internal and external customers with the evaluation of issues and adverse events which are related to the safety and efficacy of products in assigned therapeutic areas.
  • Shares medical/clinical expertise with counterparts in other functional areas such as quality assurance, regulatory affairs, marketing, manufacturing, and legal as required.
  • Provides medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities.
  • Reviews and provides assurance of medical/pharmacovigilance content and clinical relevance of regulatory safety documents including Investigators' Brochures, and ad hoc regulatory reports as assigned.
  • Applies knowledge of the various regulatory modalities used to detect safety signals in daily activities for assigned products.
  • Understands assigned products’ pharmacology and chemistry from a safety perspective, relevant nonclinical toxicology and clinical.
  • Knowledge of clinical AE profile ranges from familiarity with individual case safety reports for assigned products to comprehension of aggregate safety data across clinical trials.
  • 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.
  • Trains physicians in Medical Safety Evaluation (MSE) and clinical development on ICSR evaluation and reporting.
  • Contributes to the medical review of ad hoc regulatory reports.
  • Maintains active involvement with related functional areas within Company such as Regulatory Affairs, Clinical Development, Drug Safety, Marketing, etc. to provide safety knowledge base for decision-making.
  • Assists MSE management to communicate strategy and implement vision for the department.
  • Oversees all aspects of ICSR medical review and assessment to ensure compliance with FDA and other regulatory agencies’ rules and regulations governing adverse event reporting.

We seek candidates with the following qualifications:

  • MD or international equivalent required.
  • Residency with direct patient management and care in patients in the following areas: Internal Medicine, Oncology, Cardiology.
  • US-trained and Board eligible or Board certified is preferred. MPH is desirable.
  • Minimum of 3-5 years of experience in the pharmaceutical industry or medical practice within drug safety or drug development, 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 multi-disciplinary team matrix model.
  • Ability to serve as internal consultant and collaborate with internal and external relevant parties.
  • Demonstrated experience in leading a small multi-disciplinary business team (or sub-team) consisting of 4-6 members.
  • Demonstrated experience in leading the medical review of premarketing and/or postmarketing data, and writing high quality technical reports.
  • Demonstrated experience in assuming primary responsibility for assembling the safety sections of responses to health authority questions for a drug product.
  • Effective oral presentation and communication skills.

 

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 3018. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.