When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
The below responsibilities vary as per applicable as per the job role.
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
- Preform 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- Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool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
Regulatory Affairs
- Compares the data received from client with the information present in database for the drug applications to be remediated; identifies and updates any missing information in the database
- Creates new applications, regulatory events, product detail set, tasks, sequences and references in database based on instructions provided by client Responsible for maintaining and tracking changes in the life cycle of a medicinal product or device such as pharmaceutical strength, packaging, manufacturing sites, storage conditions or shelf life, etc. in the regulatory database per the information received from the client.
- Creation of variations in the regulatory database to track labeling, quality or administrative changes, creation of references for responses to health authority regarding PSUSA or PBRER, Referrals etc. in the European Union region for National, Centralized, Mutual Recognition and Decentralized procedures.
- Creation of reports for publishing in order to dispatch the dossier to affiliates or agency (EMA) and generation of marketing authorization status reports from the database for co-ordination of PV activities.
- Validation the data content with the latest version of SmPC and performing the xEVMPD submissions via EMA Gateway for client’s products and tracking the status of submissions and acknowledgement date.
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:
- Related experience in drug safety/ pharmacovigilance is desirable
- Good knowledge of medical terminology
- Excellent communication (written & spoken English + Japanese – JLPT N2 or above).
- JLPT N2 or higher certification or equivalent
- Experience with PMDA PV activities
- Experience working with Japanese-speaking PV case processing teams
Education:
- Degree in life Sciences, Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.), or relevant work experience in Pharmacovigilance.
- A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.