The Associate Director, Global Drug Safety Global Case Management is accountable for the oversight and workflow management of
Alexion’s Case Management activities for all adverse event reports from global clinical trials and post marketing sources. The
candidate will ensure the proper and timely management, processing and distribution of Individual Case Safety reports (ICSR)
involving Alexion marketed and investigational products.
Primary responsibility is to oversee the accurate and timely processing, distribution and reporting of post marketing and clinical
study individual case safety report information. This position will liaise with groups internal and external to Drug Safety regarding
activities associated with case processing and reporting, including but not limited to other GDS Ops groups, Development
Operations, Regulatory Affairs, and Global Operations Quality.
The Associate Director, Case Management reports to the Director, Drug Safety Operations.
Job Duties & Responsibilities
- Responsibilities for this role include, but are not limited to:
- Provides operational oversight for ICSR case management activities through both the internal team and external vendors.
- Accountable for the following:
- Directs and oversees time sensitive workload that is resourced using a mixed staffing model of internal, contracted, and third
- party case processing resources.
- Manages the day-to-day activities of the internal and external team. Collaborates with the vendor providing case
- management services and escalates service issues to the Vendor/ Alliance Management group if necessary.
- Ensures vendor case management financial invoicing is verified against the Global Drug Safety database for completeness
- and accuracy.
- Accountable for business continuity and disaster recovery plans for case management
- Collaborates with Drug Safety Intake, Policy & Vendor/ Alliance management to ensure the right talent, skill set and capacity
- exists at the CRO to meet the peaks & troughs of case processing activities
- Collaborates with the Director of Quality, Training & Compliance and the Head of Operations for developing, maintaining and
- reporting of Key Performance and Compliance Indicators (KPIs/KCIs) for operations and performance metrics
- Demonstrated proficiency in global regulatory requirements regarding ICSR safety reporting
- Expertise with Global Drug Safety databases (e.g., structure and conventions) such as ARGUS and/or Aris-G
- Experience in MedDRA coding and basic database search strategies
- Strong people and workflow management skills
- Strong organizational and prioritization skills
- Strong analytical and problem solving skills
- Strong communication skills; oral and written
- Literature search, Eudravigilance ICSR download experience desired
- Presentation skills for conveying complex technical contents to non‐expert audience
- Demonstrated commitment to quality and compliance
- Demonstrated learning agility and ability to work independently, seeking advice as required
- Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global
- Expertise with Microsoft Word, PowerPoint, SharePoint and Excel
- Understanding of clinical development processes related to clinical trials preferred
- Bachelor’s degree required; nursing or pharmacy degrees preferred
- Minimum of 5 years' pharmaceutical experience, with at least 2 years in drug safety Operations
- Advanced understanding of medical concepts and terminology
- Demonstrated knowledge of global aspects of pharmacovigilance
- Experience in medical writing
- Experience working in Drug Safety Database (ARGUS, ARIS-G, bespoke, etc)
- Excellent attention to detail
- Excellent oral and written communication skills
- Analytic and strategic thinking in complex multi-cultural situations
Boston, MA, United States
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 global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has 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). Alexion also 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). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
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. Further information about Alexion can be found at: www.alexion.com.
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.