Drug Safety & Pharmacovigilance Systems and Analytics Lead
Waltham, MA, United States
Job Description
The Global Safety System Analyst role is critical for supporting, analyzing, and optimizing pharmacovigilance and drug safety systems. The candidate will leverage Oracle SQL, Snowflake, Python, Tableau, and Spotfire expertise to ensure robust data management, analysis, visualization, and reporting. This position will contribute to enhancing the organization's ability to monitor and analyze data from various sources, such as internal drug safety data, safety data from regulatory agencies, clinical data, etc.
Responsibilities
* Develop software development life cycle (SDLC) documents including as requirement specifications, functional specifications, and validation documentation.
* Develop and maintain data sets and queries using Oracle SQL and Snowflake to support pharmacovigilance and safety reporting needs.
* Perform data extraction, transformation, and analysis using Python to support safety surveillance and regulatory compliance.
* Design and deliver interactive dashboards and visualizations in Tableau and Spotfire to communicate safety trends, signal detection, and compliance metrics to stakeholders.
* Develop and execute user acceptance test scripts to ensure system functionality aligns with business requirements.
* Collaborate with pharmacovigilance, epidemiology, and clinical teams to understand safety data requirements and ensure timely and accurate reporting.
* Monitor the performance of safety systems, troubleshoot data discrepancies, system errors, and identify process inefficiencies.
* Support the integration of new data sources, automation initiatives, and continuous improvement of safety analytics platforms.
* Provides an effective balance between IT standards and strategies with business needs to guide well-informed decisions.
Qualifications
* Bachelor’s degree in Computer Science, Information Systems, or a related field required.
* Five years of experience in the pharmaceutical or life sciences industry.
* Ability to handle system support, data management, and reporting independently.
* Proven experience with Oracle SQL and Snowflake in a healthcare, life sciences, or pharmaceutical environment is required.
* Proficiency in Python for scripting, data manipulation, and process automation.
* Advanced knowledge of Tableau and/or Spotfire for building dashboards and data visualization solutions.
* Knowledge of drug safety regulations (e.g., ICH, FDA, EMA guidelines) and pharmacovigilance data (e.g., case processing, MedDRA coding) is highly desirable.
* Strong analytical, problem-solving, and communication skills with the ability to present complex data in a clear and actionable format.
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
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About Us
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
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