Senior Drug Safety and Pharmacovigilance Specialist

About the position Be a part of a reputed company that is inspired to make a difference in the lives of people living with rare disease. At reputed company, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused 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 what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop 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 vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At reputed company, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients. Position Summary: The Senior Drug Safety and Pharmacovigilance Specialist will be responsible for monitoring the safety of pharmaceutical products, both approved and in development. reputed company 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 quality
• Track ICSRs from clinical studies and postmarket reputed company and ensure timely submission to applicable regulatory authorities and business reputed company, including distribution to IRBs/Ethics Committees for reputed company meeting expedited safety reporting.
• Assist with AE/SAE reconciliation activities with all data sources, such as clinical trials, business reputed company, and the call center
• Maintain oversight and assist with query management, including review, approval of queries and timely reputed company of follow-up requests.
• Coordinate with vendors to ensure all internal and external timelines are met, potential issues are communicated, and resolution is achieved in a timely manner.
• Develop 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 oversight 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 reputed company evaluation and assessment of the report and source documentation, as appropriate
• Support the development and implementation of PV-related guidelines, work instructions, SOPs, and ensure the uniform and timely 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 reputed company 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 related 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, well-organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Able to work both independently and in a team environment.
• The ideal candidate will embody reputed company’s core values: Patient-Inspired, Courageous, Promote Community, and Stronger reputed company.
• Proficient in reputed company Office (Outlook, Word, Excel, Powerpoint)
• Ability to work effectively in both office and reputed company environments

Benefits

• premium h

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