Quality and accuracy of reporting Drug Safety events is a critical function within Corrona. This role will support high quality collection, tracking, data management, adjudication and reporting of adverse events reported by Corrona clinical sites, for use in safety analyses. Quality Control (QC) of the data will be achieved in accordance with Company SOP’s, and relevant regulatory standards. Leadership skills will be important to this role which will require a combination of specialist-level and program-level competencies for maximum impact.
Duties & Responsibilities:
- Demonstrate a thorough understanding of Corrona’s safety data collection, reporting and analytic obligations and the key reference documents (internal and external) for assigned projects
- Demonstrate a thorough understanding of and familiarity with SOPs, work instructions and key references applicable to Corrona’s Drug Safety operations (e.g. site manuals, questionnaires, report plans, reporting templates, mapping logic)
- Demonstrate familiarity with relevant governing regulations and guidance applicable to Corrona’s observational research model and drug safety surveillance and reporting obligations, specifically.
- Demonstrate proficiency with standard tools and software systems (and their intended functionality) used to support core Drug Safety functions and deliverables for a variety of end users.
- Develop knowledge of and familiarity with standard quality checks and procedures to ensure accuracy and consistency in reporting across registries, subscribers and deliverables as applicable.
- Ensure timely and accurate Drug Safety reporting through oversight of critical functions as assigned
- Demonstrate advanced skills in core competency areas including: surveillance screens, triage of reportable cases, ICSR drafting, narrative writing, quality control (strong editorial skills), deliverable listing deliverable processing, case investigations, robust QC and feedback
- Support capacity-building objectives by providing detailed feedback and mentoring to more junior team members, as appropriate, and in accordance with internal policies and procedures
- Provide oversight and processing support for a range of contracted, safety-related deliverables (e.g. individual case safety reports, adverse event listings, QC and reconciliation reporting).
- Function as a PV lead/representative for assigned projects, workgroups and/or conference calls
- Coordinate workgroup meetings and follow-up activities for assigned deliverables, as appropriate
- Demonstrate familiarity with the Corrona registry model and the roles and responsibilities of other groups to support and promote awareness within the department.
- Actively participate in assigned program planning, departmental and cross-functional workgroups
- Support identification, preparation and delivery of cases to assigned adjudication teams to meet analytic needs and project timelines
- Participate in departmental strategic planning, problem solving, and quality improvement initiatives
- Other duties as assigned (temporary or permanent, based on company needs)
- Master’s or other advanced degree in a related discipline (e.g. MS, MPH); clinical training (preferred)
- Must have at least 2 years of relevant clinical research and/or Drug Safety experience
- Must be highly organized and detail-oriented, with excellent time management skills
- Strong written and verbal communication skills
- Ability to work independently and as part of a team
- Proficiency in MS Office: Word, PowerPoint, Excel, Access, and MS Project
- Completion of GCP, MedDRA, and other role-specific training programs, as assigned