Posted today · be early
Senior Pharmacovigilance System Architect (Argus Administrator) India, Remote (5
MMS
IndiaremotePosted 1 day ago
Skill Required
Drug-SafetyPharmacovigilanceArgus-AdministratorSafety-Database-AdministrationPV-Systems-ArchitectSenior-Pharmacovigilance-Systems-ManagerSenior-Pharmacovigilance-Project-ManagerSenior-Life-Sciences-ArchitectSystem-Architectrelated fieldISO 27001TestNGGCPandConversion OptimizationFulltime
Key highlights
- Minimum of 5 years’ experience in Information Technology or similar field required.
- Great Place to Work certified organization
- College graduate Information Technology discipline or related field, or related experience.
- Expert knowledge of scientific principles and concepts.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Familiarity with current ISO 9001 and ISO 27001 standards preferred.
Role overview
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 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 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.
Requirements
- College graduate Information Technology discipline or related field, or related experience.
- 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.
- 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 21 CFR Part 11, FDA, and GCP requirements.
- Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.
- 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.
Nice to have
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Familiarity with current ISO 9001 and ISO 27001 standards preferred.
Benefits
- MMS is a 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.
Additional details
- Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?
- Discover more about our exciting opportunities and why MMS is a great place to advance your career.
- Visit or follow MMS on LinkedIn.
- Roles & Responsibilities
- Requirements
- Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.
- Originally posted on Himalayas