Roles Responsibilities:
- Partner with IS and Business collaborators to understand how automation can improve workflow and efficiency; ensuring solutions meet business needs.
- Lead the day-to-day operations and maintenance of Pharmacovigilance systems (safety database).
- Find other opportunities for automation and process improvements within the Safety ecosystem.
- Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow IS Change Control and GxP validation process.
- Part of project/product team, willing to jump in and do programming/code-reviews etc based on demands. Hands on programming (SQL/Scripts) is expected.
- Work closely with the delivery and platform teams to ensure that the applications are aligned with approved architectural and development guidelines.
- Keeps updated on industry trends, emerging trends and standard processes for pharmacovigilance systems.
- Maintain knowledge of market trends and developments in web application development frameworks and related and new technologies to provide, recommend, and deliver standard methodology solutions.
- Responsible for supporting and leading technical root cause analysis and works with vendors to resolve Pharmacovigilance systems related issues.
- Responsible for improving performance by coaching, mentorship, and training to develop both technical and professional skills within the team.
- Support audits and inspections.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications:
- masters degree with 4 - 6 years of experience in Computer Science, IT or related field OR
- bachelors degree with 6 - 8 years of experience in Computer Science, IT or related field OR
- Diploma with 10 - 12 years of experience in Computer Science, IT or related field.
- Excellent problem-solving skills and a passion for tackling complex challenges.
- Collaborative spirit and effective communication skills to work seamlessly in a multi-functional team.
- An ongoing commitment to learning and staying at the forefront of AI/ML advancements.
- Experienced in AI/ML technologies and staying at the forefront of AI/ML advancements.
- 5 + years of experience COTS Pharmacovigilance Platforms (for example Argus) is a plus or other safety database.
- 2+ years of management or leadership experience or leadership of or leading a team of technical experts .
- Preferred Qualifications:Experienced in database programming languages, data modelling concepts, including Oracle SQL and PL/SQL.
- Experience with API integrations such as MuleSoft.
- Solid understanding of using one or more general programming languages, including but not limited to: Java or Python.
- Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients.
- Sharp learning agility, problem solving and analytical thinking .
- Experienced in managing GxP systems and implementing GxP projects.
- Extensive expertise in SDLC, including requirements, design, testing, data analysis, change control.
Professional Certifications:
- SAFe for Teams certification (preferred)
- SAFe Product Owner and SAFe Product Manager (preferred)
Soft Skills:
- Excellent analytical and troubleshooting skills.
- Excellent leadership and critical thinking abilities.
- Strong verbal and written communication skills.
- Ability to work effectively with global, virtual teams .
- High degree of initiative and self-motivation.
- Ability to manage multiple priorities successfully.
- Team-oriented, with a focus on achieving team goals.
- Strong presentation and public speaking skills.
- Ability to deal with ambiguity and think on their feet.
- Ability to influence and drive to an intended outcome.
- Ability to hold team members accountable to commitments.
