Local Drug Safety Responsible (LDSR)

Ort: United States - Field based

Funktion: Medical Affairs

Firma: Vifor Pharma

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Responsibilities

Benefit-risk management and patient safety
  • Responsible for collection and timely management of Relevant Safety information (RtSI) of all possible safety sources in the territory, e.g., Salesforce reports, HCP direct reports, Non-Interventional Studies (NIS), Market Research (MR), Patient Support Program (PSP), social media, Medical enquiries (medinfo) plus AE, Product Quality Complaint (PQC) plus AEs.   
  • Responsible for continuous benefit/risk evaluation through access to RMP and PBRER that reflects the evaluation performed at HQ.
  • Responsible for screening all relevant safety sources available for relevant safety information (RtSI).
Reachability
  • Responsible for ensuring after-hours coverage and maintaining adequate back-up coverage to ensure business continuity. 
PV related quality management system
  • Responsible for the implementation and continuous improvement of the quality system and the processes, including self-inspection.
  • Updates, reviews, and approves procedural documents (PDs) related to PV.
  • PV audit preparation, participation (as PV subject matter expert/audit lead), reviews the audit observations and CAPAs from any PV related audit. 
  • Responsible for adequate Quality Control for PV related documents.
  • Responsible for ensuring compliance of local staff with PV regulations and Vifor policies/procedures, and when needed, taking corrective and preventative action.
  • Responsible for delivery, documentation, and tracking to completion of PV training for all affiliate staff, and if applicable, commercial partners. 
  • Responsible for timely implementation of PV-related contract/service agreements, updates, and overview. 
The LDSR acts as contact person towards the Local Health Authority/ the regional authority on a 24-hour basis; name and contact details are to be notified to the L/R HA.

Together, with the moderator assigned by the responsible quality unit, the LDSR is a primary point of contact during national inspections and is the key interviewee during inspection. (The LDSR can also be assigned as moderator/inspection lead).
  • The LDSR’s main responsibility is to maintain the local Vifor PV system and monitor the safety profile (Benefit/risk balance) of Vifor products in the territory under their responsibility.
  • The LDSR’s main role in relation to product safety monitoring is to notify local authorities as soon as possible according to local legislation after a concern was confirmed to be an emerging safety issue by the Drug Safety Board in collaboration with International/EU QPPV.
  • The LDSR also provides input to the preparation of any regulatory action to be taken in response to emerging safety issues (e.g., variations, emerging safety restrictions, DHCP communications, etc.).


Tasks:
  • Oversee and manage the day-to-day activities of the local Pharmacovigilance (PV) activities.
  • If required, manage individual cases spontaneously reported to the company. This includes:
    • Process adverse event reports from any internal or external source according to required timelines, and send to Global Drug Safety, CRO, or commercial partner.
    • Conduct follow-up as required.
    • Perform global and local reconciliation of adverse events reports received (includes Medical Information, Quality Complaints etc.).
    • Digitally file, store, and archive safety-related data.
    • Track/obtain local list of all safety reports and generation of compliance metrics and KPIs. 
    • Monitor individual case safety report compliance and take the necessary corrective actions locally for late reporting.
  • If required, perform screening of local scientific and medical publications (not indexed in Embase) and social media, or other relevant sources containing safety information of products marketed in the territory. 
  • Review local initiatives (e.g., websites, registries, marketing initiatives) and clinical trials, and post authorization safety studies (PASS) protocols for compliance with PV requirements, as applicable.
  • In collaboration with International QPPV, notify local HA/regional authorities on any emerging safety issues within 24 hours after the concern was confirmed to be an emerging safety issue by the Drug Safety Board.
  • Provide input to the preparation of any regulatory action to be taken in response to emerging safety concerns issues (e.g., variations, urgent safety restrictions, DHCP communications, etc.).
  • Monitor, review, and implement PV regulations for the territory and communicate any changes to the International QPPV through a monthly transmittal form and inform other local business functions as needed.
  • Liaise with Medical Director and/or General Manager to ensure processes are in place for activities that are performed by those functions which impact PV.
  • Discuss resource issues with General Manager or escalate to International QPPV as needed.
  • Write/update local PV procedures as needed.
  • Report compliance statuses through use of metrics of key PV processes.
  • Act as trainer for local staff (and, if applicable, for commercial partner) for PV-related processes and procedures.
  • Participate in regular PV community country meetings by global QPPV office.
  • Review contracts for inclusion of AE exchange agreement language and create overview list of PV contracts/service agreements. If possible, upload contracts to global database and/or inform QPPV office of any new local PV service agreement for inclusion in PSMF.
  • Serve as the Local Qualified Person for PV or as Local PV contact for the concerned country, if required by local regulations.
  • Identify and communicate potential emerging safety issues to Global Drug Safety and the International QPPV.
  • Prepare for audits/inspections in the territory, act as the main interface to auditors/inspectors, and develop Corrective and Preventative Actions (CAPAs) in response to findings/observations with input from Global Drug Safety, Quality Management CMRS, and/or QPPV.
  • Participate in Due Diligence activities for local country licensing agreements and ensure appropriate contracts are implemented and signed.
  • Conduct qualification and ongoing audits of vendors (e.g., external archiving facility).
  • Ensure that up-to-date organization charts, job descriptions, CVs, and training records for all PV staff are available within the local company.
  • Ensure that changes to the local PV staff (permanent and temporary) are communicated to the QP office.


Qualifications

Education  
  • A Health, Life Science, or Medical Science degree, or equivalent by experience.
  • Minimum 7 years of industry experience in pharmacovigilance.
Experience
  • PV intelligence:
    • Knowledge of pharmacovigilance systems & requirements.
    • Understanding of pharmacovigilance principles, concepts, practices & standards.
    • Understanding of benefit risk management.
    • Knowledge of case processing is a plus.
  • Regulatory competency:
    • Knowledge of Good PharmacoVigilance Practices (GVP), pharmacovigilance regulations, obligations, and industry codes of practice within assigned country/territory.
    • Basic understanding of Good Clinical Practice (GCP) concepts.
  • Communication skills:
    • Excellent written & spoken English.
    • Proficient in local language.
    • Good presentation and training skills.
    • Ability to communicate effectively, verbally and in writing.
    • Proficient in Good Documentation Practices.
    • Experience interacting with auditors/inspectors and conducting qualifications audits is a plus.
  • Computer skills: 
    • Good MS Word processing, Power Point presentation & Excel spreadsheet application skills.
    • Ability to learn new computer interface systems fast.


Über uns

Bei Vifor Pharma setzen wir all unser Fachwissen, unser Engagement und unseren Unternehmergeist dafür ein, innovative Lösungen in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu entwickeln und Patienten auf der ganzen Welt damit ein besseres und gesünderes Leben zu ermöglichen. Dies motiviert uns, Tag für Tag unserer Arbeit nachzugehen.
Wollen auch Sie sich für eine bessere Welt einsetzen und mit Ihrer Arbeit zu etwas Bedeutendem beitragen? Wir bieten Ihnen als global agierendes Pharmaunternehmen die Chance, in einem weltweiten agierenden Team mitzuwirken, in dem die Möglichkeiten zur fachlichen und persönlichen Entwicklung ganz Ihrer Leidenschaft und Einsatzbereitschaft entsprechen. Mehr erfahren Sie auf viforpharma.com/career.

Was Sie von uns erwarten können

Wir kümmern uns nicht nur um das Wohl der Patienten, sondern auch um die berufliche und persönliche Weiterentwicklung und das Wohlbefinden unserer Mitarbeitenden. Unsere Wertschätzung und Anerkennung Ihrer Arbeit drücken sich in attraktiven Leistungen aus, die Ihren Lebensstandard verbessern und Ihnen Entwicklungsmöglichkeiten, berufliche Perspektiven und die Möglichkeit einer ganz persönlichen Karriereplanung in unserem Unternehmen bieten.

Einige Beispiele:

  • eine offene, sichere und integrative Unternehmenskultur, die Kreativität fördert und individuelles Potenzial erschliesst; sei es in Laboren, Produktionsstätten, im Aussendienst oder in den Büros
  • die Chance zu lernen und Ihre Fähigkeiten weiter auszubauen – mit Schwerpunkten auf geschäftliche und persönliche Leistungsfähigkeit, Führungs- und Managementkompetenzen und vieles mehr
  • ein flexibles Arbeitsumfeld, Homeoffice-Möglichkeiten und interessante Urlaubsregelungen
  • attraktive, regional angepasste Mitarbeiterbeteiligungsprogramme, die unsere Mitarbeitenden in jeder Lebenslage zusätzlich absichern, wie Pensionspläne, Beteiligungsmodelle und Sparpläne

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