IQVIA (Sr) Safety Reporting Specialist (Home/Office Based) - Novella Clinical in Morrisville, North Carolina
Novella Clinical is seeking a (Sr.) Safety Reporting Specialist (Office or Home based):
Delivers global safety reporting services including expedited and periodic safety reporting to Competent Authorities (CA) and Central Ethics Committees (CEC), for investigational medicinal products (IMPs) and Medical Devices (MD) according to ICH-GCP guidelines, regulatory requirements and Novella Standard Operating Procedures (SOPs) and/or project specific procedures.
Primary responsibilities include:
Review, preparation and submission of safetyreports (Expedited and Periodic) to all applicable Competent Authorities andCentral Ethics Committees within defined timelines for drug clinical trials andmedical device clinical investigations.
Generation and maintenance of the global safetyreporting plan for individual studies.
Oversight of third party vendors and timelycompliance reconciliation of vendor submissions.
Handle EudraVigilance user registration andmaintenance
Serve as Responsible Person for Eudravigilance, ifassigned
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Maintains a high level of understanding ofapplicable safety reporting regulations (FDA and ICH guidance, GCP regulations,EU Directives, country specific requirements etc.).
Assists in the maintenance of the safety reportingregulatory intelligence repository and informing the Safety Management team andproject teams of any pertinent updates.
Submits expedited and periodic safety reports toSponsors, Competent Authorities and Ethics Committees as applicable accordingto Novella SOPs and the project specific safety reporting plan including anycountry specific reporting requirements.
Distributes final regulatory reports to ClinicalOperations or designee for reporting to Investigators or local IRBs/ECs.
Submits ICSRs electronically through EVWeb orgateway.
Prepares and submits EudraVigilance documentsrelated to user registration and maintenance
Assumes all applicable responsibilities as requiredfor the role of “Responsible Person for EudraVigilance”
Liaises with applicable departments at Novella and/or the client to ensure timely submission of Expedited and Periodic reports toapplicable Regulatory Authorities and Ethics Committees and ensure allsubmissions are tracking appropriately and maintained in the project folders.
Communicates with Competent Authorities and EMA/Eudravigilanceon administrative and routine matters related to electronic safety reporting.
Provides input and review of responses toregulatory agency questions with regard to safety/ pharmacovigilance activities.
Maintains awareness of reporting timelines foraggregate safety reports.
Tracks regulatory submissions in the safetydatabase or project specific tracking tool, as applicable.
Assists in conducting root cause analysis for anylate regulatory reports.
Performs vendor compliance reconciliation asrequired per project
Attends internal and client project team meetingsand provides relevant team updates as required.
Assists management with, or takes ownership of, writingprocesses and developing documents related to safety reporting, includingstudy-specific processes.
Develops processes and writes documents related tosafety reporting, including study-specific processes.
Supports departmental process improvementinitiatives and collaborates with relevant departments to ensure execution.
Supports business development activities, budget,and proposal input, etc., as required.
Mentors and/or trains other safety reporting staff,as applicable.
Performs other duties as assigned by the Manager,Safety Reporting or above.
KNOWLEDGE, SKILLS AND ABILITIES:
Positive attitude and ability to interact with alllevels of staff to successfully coordinate and execute safety reportingactivities.
Excellent written and verbal communication skills.
Excellent organization skills and ability to handlemultiple priorities while adhering to applicable timelines.
Prioritizes time effectively based on projectneeds. Consistently meets deadlines. Seeks management input with anydifficulties in establishing priorities.
Advanced ability to understand, evaluate and followregulatory legislation and guidelines.
Ability to work independently, followinstructions/guidelines and demonstrate initiative.
Excellent knowledge of the clinical researchprocess and current GCP/ICH guidelines applicable to conduct of clinicalresearch.
Good knowledge of Medical Device regulations, bothpre-and post-marketing.
Excellent knowledge of electronic safety databases(preferable including Argus).
Excellent knowledge of electronic safety reportingsystems (e.g. EudraVigilance, safety database gateway).
EudraVigilance certification preferred.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Verylimited physical effort required to perform normal job duties.
Abilityand willingness to travel domestically and internationally, if required (travelrequirement <5%).
Bachelor’s Degree in one of the life sciences orclinical research and a minimum of 5 years of related pharmacovigilanceexperience and at least 2 years of relevant safety submission experience.
Previous experience in medical device trialspreferred.
Appropriate clinical research experience includingelectronic data management systems, EDC, safety database usage (Argusexperience preferred).
Excellent knowledge of issues affectingSafety/Pharmacovigilance reporting for clinical trials of IMPs and medicaldevices.
Prior experience with Eudravigilance submissionspreferred.
Computer literacy and experience working withMicrosoft Office (Word, Excel, and PowerPoint) required.
Good interpersonal and organization skillsrequired.
Ability to work independently, prioritizeeffectively and work within a matrix team environment.
EEO Minorities/Females/Protected Veterans/Disabled