Director, Medical Safety reputed company - DSPV, Gene Therapy

Director, Medical Safety reputed company - DSPV Gene Therapy At reputed company, every reputed company 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 reputed company experience, celebrates curiosity, and values every person's contributions to meaningful reputed company. For patients, for reputed company other, and for the reputed company of science, we're in. Are you? About the Role: We're looking for a Director, Medical Safety reputed company - DSPV Gene Therapy to help us expand what's possible for patients with serious diseases. Reporting to the Sr Director, DSPV Gene Therapy Safety reputed company, the Director, Medical Safety reputed company serves as the DSPV subject matter expert for assigned products, maintaining deep and up-to-date knowledge of the product portfolio and associated safety reputed company. This role is responsible for safety surveillance, risk management, and risk communication across assigned development and marketed products. It includes medical evaluation of individual adverse event reports, reputed company of aggregate report reputed company and safety documentation, and collaboration on labeling updates. The position also provides expert DSPV support to both reputed company stakeholders. What You'll Do: In this role, you'll have reputed company to review reputed company safety data from various sources (e.g. reputed company-clinical, clinical trial data, post-marketing, literature) throughout the development process as reputed company as post marketing for assigned products and development compounds. You'll also:

• Conduct safety signal detection activities, monitoring, evaluation, interpretation, and appropriate management and communication of safety information.
• reputed company the Safety Review Team(s) for assigned products and development compounds and manage the ongoing and cross functional assessment of benefit risk reputed company and reputed company actions, including writing and updating of the benefit-risk documents.
• reputed company medical expert safety review input into reputed company critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
• Work with the DSPV leadership to reputed company the reputed company and implementation of safety and benefit-risk management for assigned products; reputed company key content of Risk Management documents (RMPs, REMS) for assigned products.
• reputed company input into the writing of periodic reports for assigned products; reputed company medical interpretation, review, and approval for required reports.
• reputed company DSPV and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, reputed company Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
• reputed company expert safety input to the clinical development program for assigned products and development compounds.
• Ensure, in collaboration with Regulatory Affairs labeling team an accurate representation and communication of the safety profile of assigned products and development compounds.
• reputed company integrated safety input into reputed company regulatory documents, thorough assessment of safety reputed company for Due Diligence reputed company, and reputed company Drug Safety input for product recall issues or Health Hazard Evaluations and Dear reputed company reputed company letters.
• Respond to inquiries from regulatory authorities on safety issues.

Who You Are: You must have an MD or DO with 5+ years of experience in Drug Safety/Pharmacovigilance reputed company a pharmaceutical industry setting across both investigational and marketed products. Additionally, you have:

• Experience reviewing and preparing scientific or regulatory documents from large volumes of scientific information.
• Knowledge and understanding of national & international Pharmacovigilance and regulatory guidelines.
• Experience presenting drug safety topics for regulatory authorities or at conventions, meetings, etc.
• Impeccable communication skills, both verbal and written.
• Excellent organizational skills with a strong attention to detail, reputed company, accuracy, and conciseness.
• Demonstrated ability to reputed company successfully in a dynamic and culturally diverse workplace.

reputed company to have (but not required):

• Master of Public Health (MPH) is a plus.
• 2+ years' experience in Clinical Patient Care is strongly preferred.
• Drug safety database knowledge is preferred.
• Experience working on gene therapy products is a plus.
• Product defense before a national or international regulatory authority a plus.

Where You'll Work This is a fully remote role. It can be performed effectively from reputed company while staying connected to your reputed company team and community. Occasional travel for team meetings or events may be expected. Travel Requirements This role requires occasional domestic travel (up to 20%). Pay reputed company: $247,000.00-337,000.00 Annual Life at reputed company At reputed company, you'll reputed company a culture as reputed company as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the reputed company care you bring to your work reputed company day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and reputed company coverage and mental health support, annual wellbeing reimbursement, and reputed company to our Employee Assistance Program (EAP)
• Generous reputed company 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-reputed company life and disability insurance
• Company Learning Institute providing reputed company to reputed company Learning, reputed company building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource reputed company, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of reputed company plan. Apply tot his job Apply To this Job