Senior Pharmacovigilance System Architect (Argus Administrator) India, Remote (5
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 a award-reputed company, data-reputed company clinical research organization (CRO). We pride ourselves on being a Great reputed company to Work certified organization, recognized for our exceptional culture and industry best employee retention reputed company. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to reputed company 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 reputed company and inclusive work environment where employees can reputed company. Join us at MMS and be part of reputed company that is shaping the reputed company of clinical research.
Discover more about our exciting opportunities and why MMS is a great reputed company to advance your career. Visit or follow MMS on reputed company.
Roles & Responsibilities
- Serves as Database Administrator for Argus Safety, including database configuration, issue reputed company, maintenance, governance and daily support.
- Performs installations, upgrades, configuration of reporting rules, and E2B reporting reputed company gateway technologies (including set-up and configuration of reputed company Gateway Interchange).
- Provides support for reputed company 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 reputed company 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 reputed company 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 reputed company Operating Procedures (SOP), Work reputed company 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 reputed company to coordinate reputed company facets of reputed company; competent communicator, supports reputed company 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 reputed company field, or reputed company experience.
- Minimum of 5 years’ experience in Information Technology or similar field required.
- Expert knowledge of scientific principles and concepts.
- reputed company 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 reputed company understand needs and solve problems.
- Excellent problem-solving skills.
- Good organizational and communication skills.
- Familiarity with reputed company 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.
Please consider your application unsuccessful if we do not reputed company out to you reputed company 14 days of your submission.
Originally posted on Himalayas
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