Patient Safety Associate I

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:

General

• Develop knowledge of safety profiles, labeling, and global regulations
• Follow established project-specific procedures and workflows
• Support basic compliance with regulatory reporting timelines
• Assist with preparation for audits and inspections as directed
• Learn to review basic metrics
• Report any issues to supervisors immediately
• Follow established documentation and archiving procedures
• Observe client interactions under close supervision
• Work with team members on basic safety deliverables
• Participate in internal and client-specific training sessions and complete assigned modules in the Learning Management System (LMS).
• Ensure timely and accurate completion of Timesheets.

ICSR processing

• Monitoring of incoming reports from various sources such as mailboxes, EudraVigilance, literature searches etc.
• Perform literature searches as per search strategy, performs data entry of valid cases into the safety database.
• Triage of incoming reports for completeness, legibility, and validity, including literature abstracts/articles/citations
• Responsible for sending translation requests if any.
• 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.
• Prepares Adverse Drug Reaction (ADR) form/coversheet as required.
• Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool.
• Creates the case, performs Data Entry and moves to next workflow steps as applicable in the 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.
• Performs quality checks/validation checks.
• 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.
• Prepare basic case documentation
• Complete assigned tasks and report all challenges to supervisors
• Handling of other activities related to case processing as requested/assigned by the client, including but not limited to: End of Study Unblinding (EOSU) or performing self-identified or requested case corrections or performing deletion/deactivation requests as per client conventions and guidelines or performing coding and recoding of Study, Protocol ID, Suspect, Product, Concomitant, Treatment or Adverse Event or Other MAH reporting or Safety notification or Patient Oriented Program (POP) or Social Media (SM) related activities (as applicable)

Safety Submissions

• Monitor incoming safety reports from various sources
• Submit Individual Case Safety Reports (ICSRs) and Periodic Reports to Regulatory Authorities, Ethics Committees, investigators, and other stakeholders. 
• Maintain a strong understanding of the regulatory submission process for ICSRs and Periodic Safety Reports. 
• Perform unblinding treatment codes for safety reporting. 
• Collaborating with Project Leaders and other project team members to develop project-specific Global Safety Reporting Procedures, reporting rules, and system configurations
• Perform organization and product registration with relevant authorities on behalf of sponsors, including setting up portal and gateway submission methods. 
• Set up and deploy worldwide reporting to regulatory authorities, CECs, LECs, and investigator sites (electronic and hard copy). 
• Maintain an accurate schedule of required aggregate reports and liaise with internal technical teams and sponsors/clients to ensure timely submission compliance. 
• Create, report, and reconcile compliance metrics in collaboration with internal and external partners and stakeholders. 
• Lead safety reporting activities, ensuring ownership and accountability, including quality and submission tracking and on-time compliance. 
• Ensure accurate completion of all assigned project deliverables in accordance with Parexel standards, regulatory requirements, and client contractual obligations. 
• Prepare and file project-specific documents in the Electronic Data Management System (EDMS/eTMF). 
• Prepare for and represent the department in audits and inspections as designated. 
• Review regulatory and safety reporting intelligence to stay updated on current regulations, practices, and procedures. 
• Coach and mentor less experienced reporting associates in safety reporting activities and other work as needed. 
• Support routine project activities, including client responses, presentations, project requirement reviews, metric escalations, and budget considerations. 
• Participate in client and internal meetings, representing the Safety Reporting department for assigned projects.

 

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.
• Screen and evaluate published literature for potential adverse drug reactions (ADRs), safety signals, or emerging risks.
• Peer review of the rejected, valid and invalid’ literature abstracts/articles
• Flag relevant findings for further medical review and signal detection activities.
• 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.
• Pre-screening and review of search results concerning client’s product, for potential safety signals and forward the abstracts/articles containing potential safety signals for final assessment
• Manual insertion of full text articles in client database, if required
• Ordering full articles for abstract to ensure complete evaluation, as needed
• Interacting with internal or external contacts to resolve issues related to literature searches

Affiliate Services

• Support basic communication between global safety operations and local affiliates
• Help maintain product information in client systems
• Support safety information exchange
• Follow established local compliance procedures
• Assist with local health authority interactions as directed
• Support translation requirements
• Assist with literature monitoring tasks
• Execute basic follow-ups
• Assist with data reconciliation tasks
• Attend regular client meetings when required
• Coordinate with local affiliates to support country-specific literature screening activities, ensuring alignment with local regulatory requirements.
• Support affiliates in implementing and updating search strategies and provide guidance on screening best practices when needed.
• Ensure timely communication and data sharing with affiliates for countries with shorter timelines.
• Participate in reconciliation activities to confirm that all relevant literature records from affiliate sources are captured and databased appropriately.

Regulatory Support

• Manage regulatory applications, product registrations, and lifecycle changes in regulatory databases following client instructions.
• Assess regulatory impact for variations, create marketing packages, and maintain regulatory information systems. Support global regulatory activities (eCTD submissions, registrations, renewals, withdrawals) across multiple regions.
• Perform data remediation for acquired products, prepare EU submission packages, and track safety reports (RMP, PBRER, HASR, PASS).
• Validate data against SmPC, perform xEVMPD submissions, generate quality reports via Power BI, and provide technology support using digital adoption tools.

Regulatory Intelligence

• Responsible for researching and maintaining drug and device safety reporting related regulatory intelligence. country reviews for assigned countries
• Accountable for country safety requirement reviews and updates for assigned countries,
• Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs.
• Collaborating with and assisting the Global Pharmacovigilance Intelligence Office (GPIO) team in operational day-to-day activities.
• Participating in functional internal and external team meetings, as needed.
• Ensuring that work completed meets the requirements as in-Service Level Agreements and achieving all defined and agreed Key Performance Indicators in terms of quality, compliance and trainings for regulatory intelligence for both internal and external clients
• Maintaining up-to-date knowledge of relevant regulations and client’s and Parexel’s Standard Operating Procedures
• Other tasks as required by the management from time to time

Skills:

• Foundational knowledge of drug safety regulations and pharmacovigilance processes
• Basic analytical and problem-solving abilities
• Good communication skills
• Basic organizational and time management capabilities
• Introductory familiarity with pharmacovigilance systems and databases
• Basic computer proficiency with Windows and MS Office applications

Knowledge and Experience:

• Related experience gained in a healthcare environment is an advantage.
• Basic understanding of healthcare terminology
• Ability to learn ICH guidelines and regional requirements
• Strong desire to learn and develop skills in pharmacovigilance
• Interest in pharmaceutical or healthcare environments

Education:

• Degree in Life Sciences/Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, etc.) or equivalent qualification/work experience