Senior Medical Director, Pharmacovigilance

Boulder, CO or San Francisco, CA | Pharmacovigilance

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Job Description

Job Summary

The Medical Director, Pharmacovigilance (“PV”) will be an experienced pharmaceutical physician with strong clinical and pharmaco-epidemiologic experience in pre and post marketing settings. S/he will have the demonstrated ability to analyze safety data, identify, detect and investigate safety signals, evaluate and proactively manage risk, and provide medical safety review for Clovis investigational compounds and marketed products. S/he will provide medical input into activities associated with serious adverse events from clinical trials and post-marketing adverse events and will co-author aggregate safety documents, including NDA/MAA submission safety documents, periodic reports and responses to regulatory questions.  All activities will be done in close collaboration with PV Operations, Clinical Science, Clinical Operations, Regulatory Affairs, Quality Assurance, Medical Affairs/Medical Information and external partners using best PV practices.  The Medical Director will also represent Clovis Drug Safety at internal and external meetings and must be versed in policies and procedures regarding PV and product quality that align with prevailing FDA, EU, and other locally applicable regulations.

Job Responsibilities

  • Serve as the PV medical lead and primary point of contact for one of more programs at Clovis, providing PV supporting for compounds in clinical development and/or marketed products as appropriate.
  • Accurately identify, develop, analyze and summarize safety issues that require further evaluation utilizing data from the safety and clinical databases as necessary.
  • Author or contribute to safety sections of clinical investigator brochures, protocols, CSRs,  core safety information, labels and regulatory reports (e.g. PSUR, DSUR, PADER, Annual IND report; 6-monthly line-listings) with focus on providing overview for the medical analysis and safety sections.
  • Author or contribute to Safety sections of NDA/MAAs and other regulatory submissions (e.g., integrated summary of safety, and/or summary of clinical safety, PSMF, RMP, etc.).
  • Lead signal detection and risk management activities for designated product(s).
  • Implement proactive safety analysis strategies to further define the safety profile.
  • Lead aggregate safety data review activities and coordinate safety surveillance activities.

Skills & Requirements

Qualifications

M.D. degree or equivalent with a minimum of five (5) years’ experience in PV organizations in the pharmaceutical/biotechnology industry is required.  Oncology experience will be a significant advantage

Experience

  • Experience in clinical and post-marketing safety, and pharmaco-epidemiology.
  • Knowledge of current pre and post-marketing, US and international safety regulations.
  • Advanced ability to analyze and interpret clinical data.
  • Experience of unsupervised medical review of serious adverse event cases
  • Experience and training in MedDRA coding, and coding review
  • Strong organizational skills with ability to manage multiple projects.
  • Thorough knowledge and experience in all aspects of safety reporting for clinical trials and marketed products.
  • In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements pertaining to drug safety and risk management including ICH, CFR 21, FDAAA, and EU GVP module and able to influence decisions at all levels relating to patient safety.

Personal attributes

  • A passion for science and a commitment to the career in Drug Safety
  • Feels comfortable belonging to a multidisciplinary safety team whose members’ opinions and contributions carry equal value
  • Strong oral and written communication skills.
  • Highly motivated, flexible; excellent organizational and communication skills.
  • Ability to work both independently and as part of a multi-disciplinary team, including interacting effectively with team members in other locations both nationally and internationally.
  • Ability to manage/supervise activities in a high-pressure, fast-paced and changing environment and to ensure high quality results are delivered in a timely manner.
  • Understands and embraces the smaller company environment, that brings specific opportunities and challenges

Working Conditions

Travel as required (expected to be up to 10%).