The Drug Safety Specialist will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
Responsible for processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information, performing regulatory submissions and supporting preparation of aggregate and other study reports, as well as Medical and Product Dictionary Management activities, where applicable
Responsible for ICSR compliance and quality related processes including but not limited to quality review of ICSRs, metrics generation and late case investigation in accordance with International and local regulatory reporting requirements, where applicable.
General:
- Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, and SOPs, and Global drug safety regulations
- Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
- Assist in development of project specific safety procedures, workflows and templates.
- Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
- Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
- Delegate work as appropriate to Drug Safety Assistants
- Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
- Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
- Mentoring new recruits in the team, if required
- Archiving the source documents and relevant emails as required
- Responds to clients/customers in a timely manner
Case processing:
- Monitoring of incoming reports from various sources viz mailboxes, Eudravigilance, literature searches etc.
- Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations
- Perform a check on overall medical cohesiveness and consistency of the document
- Compares and analyses data provided by the affiliate with the data available on client application
- Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool
- Creates the case on the safety database and performs Data entry into safety database
- Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs)
- Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events
- Ensures MedDRA coding in accordance with “MedDRA Term selection: Points to Consider”
- Request follow-up and perform query management, as applicable Prepares medically cohesive case narratives based upon the reported information
- Routes the case to the next workflow state as applicable in the safety database Performs quality checks/validation checks
- Perform literature searches as per search strategy, performs data entry of valid cases into the safety database
- Case reconciliation- coordinating activities with Data Management personnel
- Line listing and tabulation generation for safety reports i.e., periodic safety reports, ad hoc safety reports etc.
- Supports compliance activities for ICSRs including late case investigation of ICSRs to various Health Authorities and Business Partners to determine the assignable cause for lateness and collection of lateness documentation including corrective actions, where applicable
- Generation, reporting and reconciliation of compliance metrics in collaboration with internal and external partners and stakeholders, where applicable
Drug Safety Reporting:
- Quality control of case reports, line listings, and tabulations Develop Expedited Reporting Procedures
- Maintain local drug safety reporting requirements
- Perform registration with relevant authorities for electronic reporting on behalf of sponsor
- Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
- Submission of safety reports to investigators via SIS (Safety Information System)
- Tracking and filing of submission cases as required Unblinding of SUSARs, as required
- Collect and review metrics for measuring reporting compliance
- Work with Global PV Information Office for collection and organization of global PV requirements
Literature Search and review:
- Formulate and maintain the search strategy/strategies in line with parameters provided by the client to enable accurate and exhaustive identification and retrieval of scientific and medical literature articles from the literature database for ad hoc literature requests, regulatory requests and DSUR requests Send the citations retrieved to the requestor in the specified format Records are reviewed, and valid cases are entered into the client database Identification and maintenance of local journals in scope for local literature search
- Performing Quality Check of the developed/updated search strategies and local journals.
- Perform periodic review of database thesauri updates and implementation of necessary changes to the search strategies in a timely manner.
- Interacting with internal or external contacts to resolve issues related to literature searches
Skills:
- Sound knowledge of drug safety and the drug development process
- Knowledge of and ability to interpret and apply global safety regulations
- Experience in data analysis and evaluation of safety data
- Good presentation skills
- Analytical and problem-solving skills
- Clear understanding of the regulatory submission process
- Proficient in database/literature searches
- Excellent interpersonal skills
- Excellent verbal / written communication skills
- Excellent organizational and prioritization skills
- Ability to work collaboratively and effectively in a team environment
- Client focused approach to work
- Ability to evaluate data and draw conclusions independently
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
Knowledge and Experience:
4 Years relevant experience is mandatory.