Roles & Responsibilities:
- Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs.
- Lead the day-to-day operations and maintenance of Pharmacovigilance (PV) systems.
- Find 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 Information Systems 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,
- Stay updated on industry trends, emerging trends and standard processes for PV systems.
- Responsible for supporting and leading technical root cause analysis and works with vendors to resolve PV 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 regulatory inspections.
Basic Qualifications and Experience:
- Masters degree with 4 - 6 years of experience in software development
OR
- Bachelors degree with 6 - 8 years of experience in software development
OR
- Diploma with 10 - 12 years of experience in software development
Functional Skills:
Must-Have Skills:
- Experienced in database programming languages, data modelling concepts, including Oracle SQL and PL/SQL.
- Knowledge of reporting tools such as Tableau, Cognos, Business Objects.
- Experienced in one or more general programming languages, including but not limited to: Java or Python.
- Excellent problem-solving skills and a commitment to resolving challenges.
- Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements.
- Experienced in SDLC, including requirements, design, testing, data analysis, change control.
- Collaborative spirit and effective communication skills to seamlessly work in a cross-functional team.
- An ongoing commitment to learning and staying at the forefront of AI/ML advancements.
- Outstanding ability to explain technical concepts to non-technical clients.
Good-to-Have Skills:
- Experienced in database programming languages, data modelling concepts, including Oracle SQL and PL/SQL
- Knowledge of API integrations such as MuleSoft
- Familiar with the ITIL framework
- 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:
- Certified SAFe Agile Software Engineer
Soft Skills:
- Strong verbal and written communication skills
- Excellent analytical and problem-solving skills
- Ability to work effectively with global, virtual teams
- High degree of initiative and self-motivation
- Ability to deal with ambiguity and prioritize
- Team-oriented, with a focus on achieving team goals
- Ability to influence and drive to an intended outcome
