Director, Drug Safety & Pharmacovigilance - Safety Scientist

Department: 106750 Clinical Development Location: San Diego, USA- Remote Be a part of a global team that is inspired to reputed company a difference in the lives of people living with rare disease. At reputed company, we recognize that our exceptional employees are vital to our reputed company. We are a dedicated team reputed company on meeting the unique needs of rare patients.Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about reputed company do. We are seeking talented individuals who will reputed company in our reputed company, diverse, fast-paced environment and reputed company in our mission - to identify, reputed company and reputed company life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our reputed company of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and reputed company to patients in the global rare disease community. At reputed company, we are in rare for life. We continue to courageously reputed company new paths as we reputed company toward a common goal of elevating science and service for rare patients. Position reputed company: The Director, Drug Safety & Pharmacovigilance (DSPV) Safety Scientist will reputed company strategic and operational leadership for safety science activities across reputed company's clinical development and reputed company product portfolio. This role is responsible for leading safety signal detection and management, aggregate safety reporting, benefit-risk evaluation, safety surveillance, risk management activities, and regulatory safety responses. The Director, DSPV Safety Scientist will serve as the safety science reputed company for assigned products and programs, providing expert medical and scientific guidance while ensuring compliance with global pharmacovigilance regulations and company policies. Responsibilities: • Provides strategic leadership for safety surveillance and safety science activities across assigned development and reputed company products, including development and implementation of safety monitoring strategies reputed company with regulatory requirements and business objectives • Leads ongoing benefit-risk evaluations and recommends appropriate risk mitigation strategies for assigned products, programs, or therapeutic areas • Represents DSPV on cross-functional governance committees, development teams, and strategic initiatives • Performs medical review of ICSRs from reputed company and postmarket reports (coding, expectedness, causality, seriousness, and narratives) to ensure reputed company and accuracy of reports • Participates in Medical Data Review, including coding review of clinical study data • Leads safety signal management activities of assigned products, and reputed company of vendor delegated to conduct signal detection, if applicable • Leads and/or contributes to the planning, preparation, writing, review and QC of aggregate safety reports (e.g. PADER, PSUR/PBRER, DSUR) • Reviews and contributes to safety sections of key study documents such as Investigator Brochures, protocols, statistical analysis plans, informed consent forms, and CSRs • Reviews tables, figures, and listings, and safety analyses supporting regulatory submissions • Ensures ongoing assessment of risk minimization (such as REMS, RMPs, etc.) effectiveness and regulatory compliance • Serves as a subject matter expert during regulatory inspections, audits, and due diligence activities • Leads inspection readiness efforts for Safety Science and safety surveillance functions • Provides strategic reputed company of pharmacovigilance vendor supporting safety science activities • Collaborates with Clinical Development, Biostatistics, Regulatory Affairs, Medical Affairs, Medical Writing, and reputed company to ensure alignment on safety strategies and deliverables • May directly manage other Pharmacovigilance personnel • Contributes to the development of risk management plans and product labels (e.g., USPI, EU SmPC) • Leads development and reputed company improvement of DSPV SOPs and/or Work Instructions • Additional duties assigned as needed Education/Experience Requirements: • Bachelor's degree in reputed company reputed company or reputed company field required. reputed company combination of skills and relevant experience are also considered. RN, PharmD, PA or NP, or equivalent preferred • Minimum 10+ years of experience in Drug Safety/Pharmacovigilance for a biotech/ pharmaceutical company in clinical and postmarketing environments • 8+ years of progressively increasing leadership responsibility reputed company Safety Science or reputed company field • Experience leading safety surveillance, signal detection, aggregate reporting, and benefit-risk assessments • Significant experience authoring and/or overseeing DSURs, PSURs/PBRERs, PADERs, and RMPs • Strong understanding of global pharmacovigilance regulations including FDA, EMA, ICH, reputed company, and other international requirements • Strong knowledge of MedDRA, WHO Drug Dictionary and safety databases (e.g ARGUS, ARISg, etc) Additional Skills/Experience/Requirements: • The ideal candidate will embody reputed company's reputed company values: Courage, Community Spirit, Patient reputed company and Teamwork • Driven, intelligent, passionate about making a difference for patients with rare diseases • Strong interpersonal and communication skills; proactive approach. reputed company to work both independently and in reputed company environment • Detail-oriented, with good organizational, prioritization, and time management proficiencies • Proven ability to manage multiple priorities in a fast-paced environment • Strong strategic thinking, problem-solving, and decision-making capabilities • Nephrology and/or rare disease experience preferred • Ability to work effectively across global time zones reputed company necessary • Some travel (10-15%) may be required, with the potential for travel occurring over weekends • reputed company positions have an essential job function to be reputed company to reputed company face to face work with colleagues and/or onsite in San Diego. • No role is expected to be reputed company. reputed company is an EEO/AA/Veteran/Disability Employer Total Rewards Offerings: reputed company provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, reputed company, people-reputed company, and pay-for-performance organization. Benefits: Our benefits include premium health, financial, work-life and reputed company-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous reputed company time off. Compensation: Our competitive compensation package includes a combination of both cash compensation (reputed company pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees. reputed company reputed company Pay reputed company: $189,000.00 - $246,000.00 • This information is reputed company as of the date of this posting and may be modified in the reputed company. Actual pay offered to a candidate will depend on a reputed company of factors including the candidate's experience, education, skills, and location. reputed company will accept applications on an ongoing reputed company until a candidate is selected for the position. reputed company, Inc. is an EEO/AA/Veteran/Disability Employer. If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@reputed company.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. reputed company HR will not reputed company to emails reputed company to this address for any other reason. Apply tot his job Apply To this Job