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Patient Safety Specialist

2 months ago

Manila, National Capital Region, Philippines Cuervo Far East, Inc. Full time

Responsibilities and Duties

Ensures compliance with both Company requirements and global and local regulatory requirements for patient safety and ensures corrective and preventative actions are taken in the event of local non-complianceEnsures that all local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF)Ensures that up-to-date organisation charts, job descriptions, training records and curriculum vitae are available for the local Patient Safety personnelMaintains oversight of all safety related processes, issues and brand activities within their country, including product risk management plans and associated activities.Ensures that an after-hours process is in place, to ensure a customer can report an AE, to respond to regulatory authority questions, to facilitate local health authority unscheduled inspections, and to facilitate the unblinding of local studies if that has been agreed as a local safety responsibilityEnsures that appropriate cover is in place so that all activities continue to be performed within the required timeframes when the PSM is out of the office, on holiday, unexpected leave etc.;Maintains an in depth knowledge of their local authority, the regulations, expectations and regulatory authority contacts and ensures that upcoming changes in legislation/guidance are notified to their regional lead for discussion and escalation to relevant stakeholders in GLOBAL PATIENT SAFETY as requiredMaintains current knowledge of the marketed status of products in their local country and reference documents such Summary of Product Characteristics or other local market data sheetPossesses working knowledge of applicable procedural documents as well as knowledge of Company products sufficient to enable training and annual refresher training of all local staff and locally engaged vendors, in safety processes and proceduresEnsures that when transfer of pharmacovigilance data occurs within an organisation or between organisations, the mechanism should be such that there is confidence that all notifications are received and that a confirmation and/or reconciliation process should be undertakenEnsures that local safety agreements are monitored and maintainedEnsures that filing and archiving practices follow the relevant Company policy and that there is no destruction of safety-related documentation without prior reference to local Patient SafetyEnsures that local processes, procedures and systems are in place for recording, processing, multiplying up and translation of AEs from spontaneous and solicited sources, AEs from local non-interventional studies and SAEs from local interventional clinical studiesEnsures that local regulatory requirements are defined with respect to reporting ICSRs to local Health Authorities, local ethics committees and investigators (including when the clinical distribution hub is used) and ensures that these reports are tracked (tracking conducted by clinical hub when used), so that details of when a report was issued and to whom, are availableEnsures that local processes are in place with respect to submission and tracking of periodic safety reports to local Health Authorities, investigators and ethics committeesIs responsible for assessment of all non-serious AEs from spontaneous sources and the upgrade of relevant events to serious in accordance with the Company Always Serious List & Designated Medical Events (DME) ListReviews local language medical or scientific literature to identify possible case reports, and forwards in a timely manner to the Company Patient Safety Data Entry Site (DES)Is trained in the use of the global tracking tool, JASPER, unless the tool is not available in the MCEnsures that the relevant GSP is notified of potential safety signals and issues (including those posted on the local health authority website), and any unsolicited reports of unexpected benefit occurring with Approved Products are forwarded to the DES and the GSP/CPLEnsures that the local legal team are informed of threatened, possible or actual legal actionEnsures a local Business Continuity Process (BCP) for Patient Safety is in place and tested at least annually QualificationsDegree/ Advanced Degree Pharmacy/Medical/Science2 years of pharmacovigilance experienceEnglish fluentWorking knowledge of Health Authority regulationsExcellent verbal and written communication skills