Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs
- Responsible for defining and implementing project and technical roadmaps that align with the strategy.
- Find opportunities for automation and process improvements within the Safety ecosystem.
- Overall accountability for technical implementation aspects of projects, including planning, architecture, design, development, and testing, to follow IS Change Control and GxP validation processes.
- Work closely with delivery and platform teams to ensure applications align with approved architectural and development guidelines.
- Identify data patterns to support informed decision-making. Collect, analyze, and interpret data to identify trends, insights, and areas for improvement.
- Keep updated on industry trends, emerging trends, and standard processes for pharmacovigilance systems.
- Lead and contribute to business case development, workshops, and RFPs.
- Responsible for supporting and leading technical root cause analysis and works with vendors to resolve Pharmacovigilance system-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.
Basic Qualifications and Experience:
- Master's degree with 4 - 6 years of experience in Computer Science, IT, or a related field OR
- Bachelor's degree with 6 - 8 years of experience in Computer Science, IT, or a related field OR
- Diploma with 10 - 12 years of experience in Computer Science, IT, or a related field.
Must-Have Skills:
- 3+ years of experience with COTS Pharmacovigilance Platforms (e.g., Argus) or other safety databases.
- Extensive expertise in SDLC, including requirements, design, testing, data analysis, and change control.
- Experienced in Agile project methodologies and working in Product Teams using JIRA.
- Experience or demonstrable understanding of Computer Systems Validation, including FDA 21 CFR Part 11, GxP Compliance, and change control.
- Strong communications skills in writing, speaking, communicating, and time management.
- High learning agility, problem-solving, and analytical thinking skills.
- Experience in requirements gathering and process improvement.
Good-to-Have Skills:
- Ability to work in a fast-paced and dynamic environment.
- Able to communicate technical or complex subject matters in business terms.
- Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients.
- Experience with Safety Signal and Risk Management platforms is a plus.
- Experienced in database programming languages and data modeling concepts, including Oracle SQL and PL/SQL.
Professional Certifications:
- SAFe for Teams certification (preferred).
Soft Skills:
- Excellent analytical and troubleshooting skills.
- Excellent leadership and strategic 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.
