Senior Pharmacovigilance System Architect (Argus Administrator) India, Remote (5

MMS is hiring a Senior Pharmacovigilance System Architect to serve as the Argus administrator for its drug safety systems. The role is remote and based in India. It is for someone with at least five years of IT experience who can handle Argus configuration, upgrades, and regulatory reporting, and who can work directly with clients as a subject matter expert.

MMS is a data-focused clinical research organization that supports the pharmaceutical, biotech, and medical device industries. It describes itself as a Great Place to Work certified organization with a global footprint across four continents.

What you will do

• Serve as Database Administrator for Argus Safety, including database configuration, issue resolution, maintenance, governance, and daily support.
• Perform installations, upgrades, and configuration of reporting rules, plus E2B reporting through gateway technologies, including setup and configuration of Axway Gateway Interchange.
• Support all systems tied to pharmacovigilance and drug safety.
• Update Argus configuration and processes as Eudravigilance regulations change.
• Support and carry out Eudravigilance testing for various clients.
• Handle case migration and database transfers, import files, and support other case processing activities.
• Lead Argus upgrades and related work.
• Provide administrator support for other safety databases such as ARISg.
• Run periodic coding dictionary updates for MedDRA and WHO drug in Argus.
• Give technical assistance to the Drug Safety Associate team for electronic submissions of serious adverse events to European agencies.
• Write procedural documents, including Standard Operating Procedures, Work Practice Documents, and Data Entry Manuals for Argus Safety.
• Generate case processing metrics, review them, suggest improvements, and support implementation.
• Keep up with regulatory requirements and make sure they align with company working practices.
• Assist with business development and capabilities efforts when needed.
• Work directly and independently with clients to coordinate all parts of projects, acting as the pharmacovigilance and drug safety systems subject matter expert.

What they are looking for

• College graduate in an Information Technology discipline or related field, or related experience.
• Minimum of 5 years' experience in Information Technology or a similar field.
• Expert knowledge of scientific principles and concepts.
• A reputation as an emerging leader in the field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Strong understanding and experience with Argus configuration and study setup.
• Strong understanding of global case processing and SAE reporting.
• Strong understanding of global clinical trial development and data.
• Good communication skills and a willingness to work with others to understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs, scientific and clinical data and terminology, and the drug development process.

Nice to have

• Hands-on experience with clinical trials and pharmaceutical development.
• Familiarity with current ISO 9001 and ISO 27001 standards.

Other details

The role is remote, based in India. MMS says it will contact candidates within 14 days of submission; if you do not hear back, consider your application unsuccessful. The listing was originally posted on Himalayas.