Senior Pharmacovigilance System Architect

Responsibilities

• Serve as the Database Administrator for Argus Safety, managing configuration, maintenance, governance, and daily support.
• Perform installations, upgrades, and configuration of reporting rules and E2B reporting via gateway technologies.
• Provide technical support for all systems associated with Pharmacovigilance (PV) and drug safety.
• Execute Argus upgrades and manage updates to configurations in alignment with Eudravigilance regulations.
• Perform case migrations, database transfers, and file importing activities.
• Manage periodic coding dictionary updates, including MedDRA and WHO drug.
• Write procedural documentation such as Standard Operating Procedures (SOP), Work Practice Documents, and Data Entry Manuals.
• Generate case processing metrics and implement process improvements.
• Act as a Subject Matter Expert (SME) when interacting with clients to coordinate project facets.

Requirements

• Degree in Information Technology, a related field, or equivalent professional experience.
• Minimum of 5 years of experience in Information Technology or a similar field.
• Expert knowledge of scientific principles and concepts.
• Proficiency with MS Office applications.
• Knowledge of 21 CFR Part 11, FDA, and GCP requirements.
• Strong problem-solving, organizational, and communication skills.
• Ability and willingness to work US EST hours.

Preferred Qualifications

• Hands-on experience with clinical trials and pharmaceutical development.
• Familiarity with ISO 9001 and ISO 27001 standards.
• Basic understanding of CRO operations and the drug development process.
• Experience with other safety databases such as ARISg.

About the Company

MMS is an award-winning, data-focused clinical research organization (CRO). We support the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory submission challenges. Recognized as a Great Place to Work, MMS fosters a collaborative and inclusive environment across a global footprint spanning four continents.