Manager Information Systems - ICSR Intake

• 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 systems (safety database)
• 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 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 you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek should have these qualifications.

Basic Qualifications:

• Doctorate Degree OR,
• 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 commitment to resolving challenges
• Collaborative spirit and effective communication skills to seamlessly work in a multi-functional team
• An ongoing commitment to learning 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
• Experience with E2BR2, E2BR3 and MedDRA

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 handling 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 solving 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 handle 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 aim to an intended outcome
• Ability to hold team members accountable to commitments