Regional Drug Safety and Regulatory Affairs Coordinator LATAM - Argentina

Ort: Argentina - Buenos Aires

Funktion: Drug Safety/Pharmacovigilance

Firma: Vifor Pharma

Georgia Izzat

International Talent Acquisition Specialist

+41 58 851 83 78

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Ihr Profil

Do you bring experience working in Drug Safety? Do you bring know-how in the area of Regulatory Affairs? Are you committed to learning and developing your skills, further? Our team in Buenos Aires is growing and in this newly created position, we are seeking a Regional Drug Safety and Regulatory Affairs Coordinator. You will be responsible to oversee and manage daily regional pharmacovigilance activities in addition to acting as the responsible point of contact for LATAM partners regarding label implementation. You will report directly to the LATAM Medical Affairs Director with a dotted line to the LATAM Regulatory Affairs Director. Tasks and responsibilities will include:
 
Pharmacovigilance

Individual Case Safety Report management supporting Peru LDSR

  • Responsible for timely processing (receipt, translation, tracking, follow-up, reconciliation and archiving) and submission  of spontaneous and solicited adverse events reports from the territory with high quality to Global Drug Safety, CRO or commercial partner
  • If required, responsible for timely submission of spontaneous and solicited  individual case safety reports (ICSRs) from the territory to the local Health Authorities

Reachability

  • Ensure after-hours coverage and maintain adequate back-up coverage in case of absence to ensure business continuity for Peru

PV related quality management system responsible for LATAM Office and supportive to Peru

  • Responsible that PV procedures are in place and kept up to date for all activities that relate to PV
  • Responsible for  compliance of staff with PV regulations and Vifor policies/procedures and when needed take corrective action
  • Responsible for delivery, documentation and tracking to completion of training for PV staff, customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and if applicable commercial partners
  • Responsible to act as PV subject matter expert for PV audits and inspections during preparation, conduct and CAPA implementation.
  • Responsible for timely implementation of PV related contract /service agreements, updates and overview.
  • Responsible for adequate Quality Control  for PV related documents
  • Act as a consultant expert on PV to partners on reports, reconciliations, audits, CAPAs

Regulatory Submissions

  • Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports (PSURs)).
  • Ensures tracking of submission and approval milestones
  • Ensures tracking of regional post-approval commitments and ensures appropriate follow-up actions
  • Participates in the development of department processes and procedures. Ensures that defined processes are developed and implemented within the regional regulatory office to track and communicate key regulatory product activities (including CCDS changes) and milestones 

The ideal candidate will bring a degree in a Life Sciences field, in addition to the following experience (not exclusive): 

  • 2 years’ experience working in Regulatory Affairs within the LATAM region
  • Knowledge of PV systems, requirements, principles, concepts, practises and standards
  • Understanding of risk management, including GVP and industry codes of practises within assigned countries/territories
  • Very strong communication skills and stakeholder management skills
  • Fluency in English and Spanish

You are an effective independent worker and are able to convince others of the importance of being PV compliant. You are able to read situations, are a focused listener and can negotiate tough agreements and settle disputes equitably, by finding common ground and getting cooperation with minimum noise. You have high attention to detail and work with a high level of accuracy, enabling you to effectively write SOPs. You are able to manage multiple projects in parallel and prioritise tasks, accordingly.  You work constructively and well with others and you are motivated by working as part of a team. You communicate in a proactive, honest and clear way and are able to communicate difficult news clearly in a timely manner. You are results-oriented, you get things done and keep focused on tasks. You work in line with the Vifor Pharma values.

Über uns

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist. Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen. Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.

Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Für mehr Informationen gehen Sie bitte auf: http://www.viforpharma.com/de/über-vifor-pharma/wer-wir-sind

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