At a Glance
- Tasks: Lead data analysis and optimisation for drug safety systems using SQL, Python, and Tableau.
- Company: Join Alkermes, a global biopharmaceutical company dedicated to improving lives through innovative medicines.
- Benefits: Enjoy a hybrid work model, competitive pay, and a culture that values diversity and inclusion.
- Why this job: Make a real impact in healthcare while working with cutting-edge technology and a passionate team.
- Qualifications: Bachelor's degree in Computer Science or related field; 5 years in pharma/life sciences required.
- Other info: Flexible work environment with 60% in-office and 40% remote; recognised as a Great Place to Work.
The predicted salary is between 43200 - 72000 £ per year.
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 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.
- Provide 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.
Drug Safety & Pharmacovigilance Systems and Analytics Lead employer: Alkermes
Contact Detail:
Alkermes Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Drug Safety & Pharmacovigilance Systems and Analytics Lead
✨Tip Number 1
Familiarise yourself with the specific tools mentioned in the job description, such as Oracle SQL, Snowflake, Python, Tableau, and Spotfire. Consider taking online courses or tutorials to enhance your skills in these areas, as practical knowledge will set you apart during interviews.
✨Tip Number 2
Network with professionals in the pharmacovigilance and drug safety fields. Attend industry conferences or webinars, and connect with people on LinkedIn who work at Alkermes or similar companies. This can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and regulations in drug safety and pharmacovigilance. Understanding current guidelines from organisations like the FDA and EMA will demonstrate your commitment to the field and your ability to contribute effectively to the team.
✨Tip Number 4
Prepare for potential technical assessments by practising data analysis and visualisation tasks using the tools listed in the job description. Being able to showcase your problem-solving skills and analytical thinking during the interview will greatly enhance your chances of landing the job.
We think you need these skills to ace Drug Safety & Pharmacovigilance Systems and Analytics Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in pharmacovigilance and drug safety systems. Emphasise your expertise with Oracle SQL, Snowflake, Python, Tableau, and Spotfire, as these are crucial for the role.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about drug safety and how your skills align with the responsibilities outlined in the job description. Mention specific projects or experiences that demonstrate your analytical and problem-solving abilities.
Showcase Relevant Skills: Clearly list your technical skills related to data management and analysis. Highlight your proficiency in Python for scripting and data manipulation, as well as your experience in creating dashboards using Tableau or Spotfire.
Demonstrate Knowledge of Regulations: Include any knowledge or experience you have with drug safety regulations such as ICH, FDA, or EMA guidelines. This will show that you understand the compliance aspects of the role and can contribute effectively from day one.
How to prepare for a job interview at Alkermes
✨Showcase Your Technical Skills
Make sure to highlight your experience with Oracle SQL, Snowflake, Python, Tableau, and Spotfire during the interview. Be prepared to discuss specific projects where you used these tools, as this role heavily relies on data management and analysis.
✨Understand Drug Safety Regulations
Familiarise yourself with key drug safety regulations such as ICH, FDA, and EMA guidelines. Being able to discuss how these regulations impact pharmacovigilance will demonstrate your industry knowledge and commitment to compliance.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and ability to handle data discrepancies or system errors. Think of examples from your past experience where you successfully navigated similar challenges.
✨Emphasise Collaboration Skills
This role requires collaboration with various teams, so be ready to discuss your experience working in cross-functional teams. Highlight instances where you effectively communicated complex data insights to non-technical stakeholders.