Manager, Drug Safety Specialist

1 week ago

Jersey City, New Jersey, United States Mitsubishi Tanabe Pharma Full time
Job Summary

Mitsubishi Tanabe Pharma America is seeking a highly skilled Manager, Drug Safety to support signal detection activities and medical analyses to evaluate and characterize safety topics for products. The successful candidate will work closely with the Drug Safety Global Safety Team (GST) Chair (Medical Director) to perform signal management process activities for assigned products, including signal tracking, safety data analysis, and presenting in the GST governance meetings.

Key Responsibilities
  • Partner with Medical Directors and the GST Chair to provide strategic product risk management throughout the product lifecycle for assigned products.
  • Provide expertise to develop and manage product safety/risk profiles, including performing safety analyses and evaluations, interpreting safety information to make recommendations, and leading safety data review meetings as needed.
  • Draw on knowledge and/or experience in qualitative and quantitative signal detection methods.
  • Perform robust and independent clinical safety analysis with a focus on medical interpretation of safety data.
  • Analyze and interpret data from multiple sources, including clinical trials, safety databases, literature, etc.
  • Collaborate with Medical Directors and cross-functional members of the GST to initiate and complete GST deliverables as required, supporting GST activities such as preparing and presenting data, compiling meeting minutes, and updating signal tracking information.
  • Author safety data summarization of applicable information for New Drug Applications (NDA), New Drug Submissions (NDS), Amendments, Supplements, Safety Reports, and general correspondence for all assigned products.
  • Lead and produce high-quality and timely written documentation for PV safety documents, including Periodic Safety Update Reports (PSUR), DSUR, PADER, safety sections for labels/IBs/regulatory submissions, Safety Surveillance Plans, and CCDS.
  • Support the writing of regional REMS/RMPs for assigned MTPG global products as needed.
  • Provide support for US FDA and Health Authority safety interactions/responses for assigned MTPG products regarding safety and risk management, both written and verbal.
  • Utilize technical combination product and device knowledge, regulatory expertise, and lessons learned to shape MTPG best practices.
  • Collaborate effectively across a global matrix organization to support global cross-functional consensus on benefit-risk analysis, safety conclusions, and their impact for product safety profiles.
  • Mentor junior pharmacovigilance (PV) personnel in their functions.
  • Perform other departmental duties as assigned.
  • Collaborate with, communicate with, and as required oversee the work of external service providers or suppliers directly involved in the drug development process.
Requirements
  • Minimum BA/BS in a healthcare-related or Biomedical Science field; advanced degree preferred.
  • Minimum of 5 years in the pharmaceutical industry experience with at least 2 years of experience in US and international Drug Safety.
  • Solid understanding of scientific principles and regulatory requirements relevant to global drug and drug-device combination product development, registration, and post-market support.
  • Strong knowledge of global regulatory requirements related to pharmacovigilance and drug safety.
  • Strong knowledge in signal detection, evaluation, aggregate data analysis, and interpretation.
  • Experience using analytics tools (MS Power BI, IBM Cognos, SpotFire, etc.).
  • Solid understanding of US and International Safety reporting regulations and guidelines (in particular, ICH clinical safety guidelines).
  • Excellent interpersonal, relationship management, and decision-making skills with the ability to collaborate effectively with other cross-functional groups in a matrix organization.
  • Excellent communication skills, verbal and written.
  • Required to travel domestically and internationally typically up to 10-15%.
What We Offer

Mitsubishi Tanabe Pharma America offers a competitive benefits package, including medical and dental health benefits, short-term and long-term disability plans, company-paid and supplemental life insurance, and additional voluntary benefits such as critical illness insurance, accident insurance, legal plan, and ID theft protection. We also provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

The salary range for this position is $93,000 - $149,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.

This position is eligible to participate in our annual Short-Term Incentive (STI) program. Specific information about the plan, including eligibility rules and target, will be furnished upon hire.

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