Patient Safety Associate II/Patient Safety Specialist

Patient Safety Associate II/Patient Safety Specialist - Japanese

Parexel

Location:
India

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

Patient Safety Associate II/Patient Safety Specialist - Japanese role at Parexel. The responsibilities vary as per applicable as per the job role and include general drug safety accountabilities, case processing, drug safety reporting, regulatory affairs, and literature search and review.

Job Responsibility:

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
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Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool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
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
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
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

Requirements:

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)
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
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

Additional Information:

Job Posted:
January 06, 2026

Work Type:

Remote work

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Job Link Share:

Patient Safety Associate II/Patient Safety Specialist - Japanese

Parexel

Location:
India

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 06, 2026

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Patient Safety Associate II/Patient Safety Specialist - Japanese

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Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:January 06, 2026

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