Director, Medical Safety

We need to output HTML fragment with sections: About the role, Responsibilities (maybe "What You'll Do"), Requirements/Qualifications (maybe "Who You Are"), Benefits, Pay, Schedule (if present). Also maybe "Where You'll Work". The instructions: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use

• for any list of duties/requirements/benefits, and

  for prose. Do NOT repeat the job title as a heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

  or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. We need to extract substantive content. The posting includes: - Intro paragraph about Insmed (mission, recognition). This is about company, not role. Should we include? It's not a section heading but could be part of "About the role"? Actually "About The Role" heading appears later. The intro before that is generic company description. Might be considered part of "About the role"? But the instruction says use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have an "About the role" section that includes the description of the role (the paragraph after "About The Role"). Thus we need sections: - About the role: includes the paragraph after "About The Role" up to "What You'll Do". Actually the text: "About The Role We’re looking for a Director, Medical Safety on the Drug Safety & Pharmacovigilance team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, DSPV Medical Safety, you’ll oversee a team of Pharmacovigilance (PV) Scientists responsible for signal detection, risk management, aggregate safety reporting, and clinical trial safety support and ensure the delivery of high-quality safety surveillance activities throughout the product lifecycle while maintaining compliance with global pharmacovigilance regulations and company procedures. You will also serve as a strategic partner to Medical Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Clinical Operations, and Quality Assurance to ensure timely identification, assessment, and communication of product safety risks." That is the role description. - Responsibilities: "What You'll Do" bullet list. Many items. - Requirements/Qualifications: "Who You Are" includes education, experience, etc. Also "Nice To Have (but Not Required)" could be separate but maybe we can include under Requirements or Skills. The instruction: prefer few substantive sections over many thin ones. Could combine Requirements and Qualifications into one section. Could also have Skills section for technical skills. But we can combine. - Benefits: "Life at Insmed" includes benefits details. That's substantive. - Pay: "Pay Range $185,000.00-252,500.00 Annual". That's specific. - Schedule: "Where You’ll Work This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Travel Requirements Minimal travel expected – up to 15%". That's schedule/location/travel. So we can have a Schedule section. We must not include boilerplate like EEO, legal, application instructions, etc. Remove duplicated lines. We need to output only HTML fragment, no /, no markdown fences. We need to use

  for each section heading. Use

  • for any list of duties/requirements/benefits. Use

    for prose. We need to preserve all substantive information; do not invent or summarize away detail. Thus we need to convert bullet points into

    • . For responsibilities list, each bullet starts with a verb (e.g., "Allocate resources across products and development programs to ensure timely execution of safety deliverables." etc). We'll need to capture each bullet. Let's extract responsibilities list from "What You'll Do In this role, you’ll have the opportunity to lead, mentor, and develop a team of PV Scientists. You’ll also:" then list. List items: - Allocate resources across products and development programs to ensure timely execution of safety deliverables. - Foster a culture of scientific excellence, collaboration, continuous improvement, and regulatory compliance. - Provide scientific oversight of routine and ad hoc signal detection activities for investigational and marketed products. - Ensure timely identification, evaluation, documentation, and communication of emerging safety signals. - Review and approve signal evaluations and support safety governance activities. - Lead the preparation, maintenance, and lifecycle management of core Risk Management Plans (RMPs) and associated safety documents. - Support implementation and evaluation of risk minimization measures. - Ensure consistency between RMPs, Core Safety Information, Investigator's Brochures, and product labeling. - Oversee preparation and scientific quality of aggregate safety reports - Provide strategic guidance on benefit-risk assessments and safety conclusions. - Provide pharmacovigilance support to clinical development programs from First-in-Human through post-marketing. - Partner with Medical Safety Physicians to ensure consistent medical and scientific evaluation of safety data. - Collaborate with Regulatory Affairs to support regulatory submissions and responses. - Ensure compliance with global pharmacovigilance regulations, including FDA, EMA, ICH, and other applicable health authority requirements. - Support regulatory inspections and internal/external audits. - Interface with Quality Assurance regarding inspections, audits, CAPAs, and compliance initiatives. - Lead the evaluation, implementation, and continuous optimization of AI-enabled tools for signal detection, aggregate reporting, literature surveillance, case review, and other pharmacovigilance activities. - Identify opportunities to streamline workflows, improve data quality, and increase operational productivity while maintaining regulatory compliance and scientific integrity. Note some lines may have missing period; we keep as is. Now "Who You Are" includes: "You have a Master's degree or PhD in Pharmacy, Pharmacology, Life Sciences, Nursing, Public Health, or a related scientific discipline along with 10 years of experience in within the pharma/biotech industry as well as minimum of 5 years of direct people management experience leading PV Scientists or Medical Safety professionals" Then "You Are Or You Also Have" seems duplicated; but we need to capture the list: - Demonstrated experience supporting both clinical development and post-marketing pharmacovigilance activities - Extensive experience in signal detection and signal management. - Experience with safety databases (e.g., Argus, ARISg) and safety analytics tools is preferred. - Strong understanding of benefit-risk assessment methodologies. - Exceptional experience authoring and managing Risk Management Plans (RMPs), aRMM and REM. - Significant experience preparing and overseeing aggregate safety reports (DSURs, PSURs/PBRERs, Annual Reports). - Experience supporting clinical studies throughout the product development lifecycle. - Thorough knowledge of ICH guidelines, FDA, EMA, and global pharmacovigilance regulations - Excellent leadership with strong scientific and analytical skills. - Strategic thinker with strong project management skills. - Ability to influence cross-functional stakeholders and PV senior leadership. - Detail-oriented with the ability to manage multiple priorities in a fast-paced environment. - Demonstrated commitment to quality, compliance, and continuous improvement - exceptional written and verbal communication skills - Strong understanding of AI, automation, and advanced analytics applications within pharmacovigilance and drug safety. - Proven ability to evaluate and implement innovative technologies that improve operational efficiency, data quality, and regulatory compliance. Then "Nice To Have (but Not Required)" list: - Advanced scientific degree - Experience in pulmonary disease, rare diseases and gene therapy - Experience participating in regulatory inspections and audits - Experience leading global pharmacovigilance initiatives - Familiarity with safety data visualization and signal detection methodologies - Experience working in a matrixed global organization We could combine these under Requirements/Qualifications section, maybe separate "Nice to have" as a sublist but still within same section. Now Benefits: "Life at Insmed" paragraph includes bullet list of highlights. Let's extract: "Highlights Of Our U.S. Offerings Include Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back" We need to preserve all substantive information; we can turn each line into
    • . Also note the first line starts with "Highlights Of Our U.S. Offerings Include". Could treat as intro sentence then list. Thus Benefits section: maybe a

      intro then

      . Now Pay: we have "Pay Range $185,000.00-252,500.00 Annual". That's specific; we can put in

      . Schedule: "Where You’ll Work This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Travel Requirements Minimal travel expected – up to 15%". That's schedule. We should not include "Where You'll Work" heading? The instruction says use

      for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can use Schedule heading. Now we need to ensure we don't include filler like "commensurate with experience". Not present. Now we need to remove boilerplate: The intro paragraph about Insmed mission and recognition maybe not needed as a section; but could be considered part of About the role? However the About the role section already has role description. The intro paragraph is more about company; we could include it as a brief preamble before sections, but the instruction says use

      for section headings; we could just have a

      at start with that intro. It's substantive info about company; we should preserve it. Not a heading though. So we can output a

      with that intro, then sections. But we need to avoid duplication: The intro includes "At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you?" That's substantive; we keep. Now after that we have "About The Role" heading; we will make

      About the role

      and then

      with the role description. Now responsibilities:

      Responsibilities

      then
      • ... etc. Now Requirements/Qualifications: maybe

        Requ