Safety Systems Analyst
- Permanent
- PVG & Drug Safety, Drug Safety Systems
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Hobson Prior are currently looking for Safety Systems Analyst to join a biopharmaceutical research organisation who specialize in oncology product development and pioneering medicines that are used all over the world. This position will entail providing Safety systems support for the Pharmacovigilance department including Argus and other technical based solutions.
Job Responsibilities:
- You will contribute to the maintenance and management of the Pharmacovigilance safety systems. This includes all the necessary configurations such as, user configuration, workflows, products & licenses, expediting rules, E2B reporting, etc.
- Assist with configuration and validation of safety system updates and upgrades, including but not limited to the development and execution of test scripts to verify compliance to system configuration.
- Recognise, collate, and respond to issues raised concerning the organisations safety systems.
- Assist, develop, and perform data retrievals for all other Pharmacovigilance needs, e.g. compliance analyses and metrics, review of safety profiles of the company's products.
- Day-to-day Pharmacovigilance safety system support to ensure continuity of reporting. Support submission activities associated with expedited individual case safety reports to Regulatory Authorities and distribution of ICSRs to business partners, as needed.
- Contribute to the maintenance of all other systems in Pharmacovigilance, including but not limited to signal detection system (e.g., reporting systems, MedDRA upgrades).
- Offers safety user support and system administration. Assists with the development of safety system training materials and delivers training to employees with user training, as requested.
- Assist in the generation of complete and accurate periodic regulatory reports and ad-hoc reports, for various constituencies with an interest in the safety database, e.g., Operations, Clinical, and Safety Review Team.
- Perform testing, validation and execution of E2B certification with partners and regulatory authorities.
- Assist in the creation / maintenance/ or delivery of training on Pharmacovigilance-specific procedural documents referring to the use of the organisations Safety Systems.
- Partakes in the establishment of Data Entry Guidelines to ensure consistent and accurate data entry.
Key Skills:
- Excellent verbal and written communication skills.
- Must demonstrate a keen attention to detail and timelines.
- Ability to work both independently and in a collaborative team setting.
- Capability to interpret and follow regulatory guidelines.
Requirements:
- Bachelor's degree in computer science, bioinformatics or related field required.
- A minimum of 3 to 4 years of progressive experience in Systems Management or Safety Data Management (Argus experience required).
- Prior experience in the pharmaceutical or biotechnology industries is required.
- Experience with electronic submissions of safety data to regulatory authorities preferred.
- Experience in working on IT projects, GXP and validation requirements including documentation in a regulatory environment.
- Strong knowledge of pharmacovigilance terminology and system data entry conventions.
- Demonstrated technical, analytical and problem-solving skills as they pertain to safety database systems preferred.
- Broad knowledge of Pharmacovigilance Databases (e.g. Argus, ARISg).
- Programming experience with SQL or sufficient demonstrated proficiency required.
- Experience with E2B software (e.g., Axway) preferred.
- Familiarity with reporting tools such as Spotfire, Cognos or Business Objects preferred.
- Prior Experience in Business Configuration in Argus preferred.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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