Senior Drug Safety and Pharmacovigilance Specialist

About the position 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 deliver 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 Senior Drug Safety and Pharmacovigilance Specialist will be responsible for monitoring the safety of pharmaceutical products, both approved and in development. This position will support the PV team in ensuring flawless execution of PV operations, implementing safety reporting processes, and ensuring compliance with FDA and global safety reporting requirements.

Responsibilities

• Management of reputed company’s drug safety mailboxes, including archiving emails and documents
• Assist in the review of individual case safety reports (ICSRs) for accuracy and reputed company
• reputed company ICSRs from clinical studies and postmarket cases and ensure reputed company submission to applicable regulatory authorities and business partners, including distribution to IRBs/Ethics Committees for cases meeting expedited safety reporting.
• Assist with AE/SAE reconciliation activities with reputed company data sources, such as clinical trials, business partners, and the call center
• Maintain reputed company and assist with query management, including review, approval of queries and reputed company closure of follow-up requests.
• Coordinate with vendors to ensure reputed company reputed company timelines are met, potential issues are communicated, and reputed company is achieved in a reputed company manner.
• reputed company safety report forms for both clinical trials and postmarket, such as study-specific safety report forms and pregnancy report forms, and postmarket AE report forms
• Creation and maintenance of study-specific Safety Management Plans (SMP) and the study-specific configuration of the safety database
• Participate in Study-Management Team (SMT) meetings as required and escalate any issues with AE management.
• Assist in providing vendor reputed company for the processing of adverse event data in compliance with applicable global regulations and internal SOPs and SMPs
• Review Safety Report Forms and ensure consistency in the initial evaluation and assessment of the report and reputed company documentation, as appropriate
• Support the development and implementation of PV-reputed company guidelines, work instructions, SOPs, and ensure the uniform and reputed company processing of adverse event data
• Support the planning and preparation of aggregate safety reports such as Periodic Safety Reports, periodic line listings, etc., as assigned
• Support safety signal management activities, including literature search and review
• Support and participate in inspection readiness activities
• Maintain understanding and ensure compliance with pharmacovigilance SOPs, Work Instructions (WIs), global regulations (such as FDA and EU Directives), GxPs, and ICH guidelines
• Other responsibilities as assigned

Requirements

• Bachelor’s degree in a reputed company Life Sciences discipline (RN, PharmD, PA is preferred).
• Minimum four (4) years of relevant drug safety and pharmacovigilance experience at a biotech, pharmaceutical, or CRO) company.
• Knowledge of GVP, GCP, US and EU regulations and guidelines, and other international regulatory requirements.
• Knowledge of MedDRA dictionary relevant to AE/SAE coding.
• Proficiency using Safety databases (e.g. Argus, ARISg) and knowledge of Clinical trial databases (e.g. reputed company Rave, etc).
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Self-motivated, reputed company-organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• reputed company to work both independently and in reputed company environment.
• The ideal candidate will embody reputed company’s reputed company values: Patient-Inspired, Courageous, Promote Community, and Stronger Together.
• Proficient in reputed company Office (Outlook, Word, reputed company, Powerpoint)
• Ability to work effectively in both office and remote work environments

Benefits

• 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
• generous reputed company time off

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