Senior Pharmacovigilance System Architect (Argus Administrator) - US

mmsholdingsinc; Deutschland; On-site; EUR 90,000 - 120,000; Full time

Job summary

MMS Holdings seeks a Senior Pharmacovigilance System Architect to lead Argus Safety administration and PV system configuration for a global client base.

You will drive installations, upgrades and E2B processes, ensuring compliance with evolving global regulations and data standards within a dynamic CRO environment.

Qualifications

• Minimum of 5 years’ experience in Information Technology or a related field.
• Expert knowledge of scientific principles and concepts.
• Proficiency with MS Office applications.
• Strong communication and problem solving skills.
• Familiarity with ISO 9001 and ISO 27001 standards.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology, and the drug development process.

Responsibilities

• Serve as Database Administrator for Argus Safety, including database configuration, issue resolution, maintenance, governance and daily support.
• Performs installations, upgrades, configuration of reporting rules, and E2B reporting via gateway technologies (including set-up and configuration of Axway Gateway Interchange).
• Provides support for all systems associated with PV and drug safety.
• Performs updates to Argus configuration and processes as per changing EudraVigilance regulations.
• Provides support and execution of activities related to EudraVigilance testing for various clients.
• Performs case migration/database transfers, file importing and supports other case processing activities.
• Provides leadership in executing Argus upgrades and related activities.
• Provides administrator support for other safety databases such as ARISg.
• Performs periodic coding dictionary (MedDRA & WHO drug) updates for Argus.
• Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse events to European agencies.
• Writes procedural documents including SOPs, Work Practice Documents, and Data Entry Manuals for Argus Safety.
• Generates case processing metrics, reviews and makes suggestions and supports process improvement implementation.
• Maintains technical expertise of regulatory requirements and ensures alignment with company working practices.
• Assists with business development and capabilities efforts as needed.
• Interacts directly and independently with client to coordinate all facets of projects; communicates effectively as PV/drug safety systems SME.
• Strong understanding and experience working with Argus configuration and study setup.
• Strong understanding of global case processing and SAE reporting.
• Strong understanding of global clinical trial development and data.

Skills

Argus Safety

PV system administration

EudraVigilance

SOP writing

Data governance

System upgrades

Client coordination

Regulatory knowledge

Education

IT degree

Tools

Argus Safety

Axway Gateway Interchange

ARISg

Job description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

SeniorPharmacovigilance System Architect

We are recruiting for an experiencedPharmacovigilance System Architect (Argus Administrator SME) tojoin our US team.

Roles & Responsibilities

• Serves as Database Administrator for Argus Safety, including database configuration, issue resolution, maintenance, governance and daily support.
• Performs installations, upgrades, configuration of reporting rules, and E2B reporting via gateway technologies (including set-up and configuration of Axway Gateway Interchange).
• Provides support for all systems associated with PV and drug safety.
• Performs updates to Argus configuration and processes as per changing EudraVigilance regulations.
• Provides support and execution of activities related to EudraVigilancetesting for various clients.
• Performs case migration/database transfers, file importing and supports other case processing activities.
• Provides leadership in executing Argus upgrades and related activities.
• Provides administrator support for other safety databases such as ARISg.
• Performs periodic coding dictionary (MedDRA & WHO drug) updates for Argus.
• Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies.
• Writes procedural documents including Standard Operating Procedures (SOP), Work Practice Documents, and Data Entry Manuals for Argus Safety.
• Generates case processing metrics, reviews and makes suggestions and supports process improvement implementation.
• Maintains technical expertise of regulatory requirements and ensures alignment with company working practices.
• Assists with business development and capabilities efforts as needed.
• Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client capabilities as PV/drug safety systems SME.
• Strong understanding and experience working with Argus configuration and study set up.
• Strong understanding of global case processing and SAE reporting.
• Strong understanding of global clinical trial development and data.

Requirements

• College graduate Information Technology discipline or related field, or relevantexperience.
• Minimum of 5 years’ experience in Information Technology or similar field required.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.