Alexion Pharmaceuticals Safety Data Management Specialist III in Boston, Massachusetts
Responsible and accountable for all aspects related to the handling of safety information originating from post-marketing, clinical trials, literature, and other sources.
Investigation, documentation, medical research, and processing of incoming Adverse Drug Events (ADEs) or Reactions (ADRs) as per Alexion’s SOPs.
Reviews cases for expectedness and seriousness.
Maintains in-depth knowledge of the assigned projects, regulatory requirements, and other safety-related initiatives.
Supports the team on safety-related issues.
Contributes to regulatory responses, IBs, study protocols, CRFs, Reports, and other documents as required.
Reviews and assesses data to identify potential safety related signals
Retrieves information from the safety database for use in aggregate safety reports for dissemination to PV and to fulfill regulatory compliance.
Works as an effective team member in Global PV Group
Collaborates with GPV Group on effective processes with 3rd parties for any outsourced activities
Work closely with safety physician and support the data collection and assessment needs for SMTs, CSRs, GSC, Adhoc requests etc.
Job Duties & Responsibilities
Effectively triages cases based on seriousness and expectedness
Responsible for providing quality documentation of safety data, particularly serious adverse events (SAEs), through direct contribution in a matrix environment.
Ensures compliance with health authority regulations in all aspects of drug safety data processing and reporting.
Processes SAEs from receipt to case closure in the safety database including query generation.
Conducts follow-up to obtain critical or missing AE information for appropriate medical assessment.
Compilation of Safety Reporting Plan covering SAE workflow between CRO and ALXN
Collaborates with team members on the development and implementation of PV standard operating procedures (SOPs)
Maintains and updates documentation of personal training records
Oversees electronic and hard copy document management, retrieval, and archiving of PV information including individual case summary reports to partners, CROs, and health authorities
Reviews and reconciles SAE data between clinical and safety databases
Interacts with clinical operations, medical information, regulatory affairs, commercial, CRO and data management groups on PV related issues for assigned study protocols
Remains informed of all appropriate current health authority regulations and guidance, including those from ICH
Collaborates with team members on regulatory responses, IBs, study protocols, CRFs, Reports, and other documents as required
Support safety physician in data collection and assessment needs for SMTs, CSRs, GSC, Adhoc requests etc.
Support unblinding procedure for blinded trials
Develop Safety Reporting Plan for the clinical trials assigned and work with CRO supporting the study on process implementation
Ensure Clinical Trial activities are being performed as per SRP & protocol
Identify quality issues & trends and notify appropriate team leader
Perform quality check on ICSR’s
Relies on experience and judgment to plan and accomplish goals.
Participate in the process improvement effort in developing, implementing, and documenting all PV training, conventions and training other team members and CROs with respect to ALXN data collection conventions
Responsibility for trains fellow Alexion colleagues and vendors on appropriate adverse event reporting
Natural Science degree with minimum of 3 years of clinical safety/CRA or health science experience.
Minimum 3 years of industry experience
Minimum of 3 years clinical safety experience or 5+ years of relevant experience in the healthcare, clinical or bio-pharmaceutical field, or other related experience;
Good understanding of drug development, Drug Safety requirements and health authority regulations for adverse event reporting, and working knowledge of the importance of regulatory compliance
Strong computer and database skills, experience with PV databases; ARGUS database experience a plus
Strong organizational, oral/written communication and project management skills
Attention to detail and a high commitment to the quality of all projects and accountability for deliverables
Demonstrated ability to manage multiple projects and prioritize
Ability to solve complex problems and suggest creative solutions
Proactive, positive approach to projects and constructive, interactions with colleagues
Direct experience in a pharmaceutical or biotechnology company Pharmacovigilance/Drug Safety Department preferred
Health Care degree preferred
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). In addition, Alexion has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.
Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexion.com.
Alexion is an Equal Opportunity /Affirmative action employer