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Sr Manager, Diagnostic - Brazil  

Company managed [?] Still accepting applications

Posted on : 15 April 2017

Project Description

 

 

Position Summary

The Sr Manager, Diagnostic of Alexion will manage relationship with logistic vendor to ensure compliance with current Service Level Agreements.

Principal Responsibilities

  • Identify new laboratories that offer high sensitivity Flow Cytometry services within the territories where we operate. Develop necessary relationships and ensure quick operational readiness through vendor.
  • Identify key laboratories and / or health care centers with current available ADAMTS13 testing capabilities or diagnostic centers of reference with interest to partner on developments of necessary capabilities.
  • Educate laboratories on the scientific rationale for appropriate patients to test for PNH  based on published literature and clinical experience.
  • Profile laboratories on the volume of testing performed on diagnostic pathway patients
  • Educate laboratories on International PNH and aHUS testing trends
  • Educate and facilitate the exchange of scientific information that supports recommended PNH and aHUS testing methods
  • Identify, build, and leverage relationships with PNH flow cytometry KOLs
  • Utilize key opinion leader (KOL) network so share best practices among laboratories
  • Collaborate with medical affairs to identify research projects related to PNH and aHUS diagnostics
  • Supervision and or execution of the following activities:
  • Ensure quality standards of sample logistics meet testing labs requirements.
  • Execution of logistics coordination of diagnostic samples, whether national or abroad
  • Provide orientation and support to physicians on the logistic process of the samples.
  • Develop and improve logistics training documents and tutorials related to sampling and logistics of diagnostics processes
  • Act as Pharmacovigilance deputy when requested and  assumes full responsibilities for Pharmacovigilance activities that the DSO has assigned to him/her.  This person must be trained on all the global and local PV SOPS.  In absence or unavailability of the DS, the Deputy Drug Safety Officer is responsible for the responsibilities of the DSO:
    • Ensure adverse events (AEs) and other safety findings (e.g., pregnancy, off label use, overdose, abuse, lack of effect, etc.,) are collected, processed and reported from all sources appropriately in accordance with global SOPs, local SOPs and regional regulations
      • Initiate immediate review of AEs and in collaboration with the EUQP and GPV to determine if there are any changes in the benefit / risk profile of the product.
      • Collect, translate, process, document and submit PV information to ALXN GPV
      • Follow up with reporters to obtain additional information/clarification
      • Submit ICSRs to appropriate local or regional regulatory/health authority per local and global SOPs
    • Forward all requests from local or regional regulatory/health authority to GPV per SOPS
    • Ensure Quality Management System with regards to the PV system is in place.
    • Delivers education and training within the local organization (as well as any 3rd party contractors involved in PV activities) and ensures compliance with PV training within the country including documentation of attendees and topics covered
    • Maintain compliance with PV SOPs
    • Perform periodic literature screening in accordance to global and local SOPs
    • Performing regular local regulatory intelligence
    • Support the EU-QPPV in forwarding further information relating to the assessment and evaluations of a drug’s benefit-risk ratio when requested by the EU Regulators.  All corresponding queries shall be forwarded immediately to and agreed with EU-QPPV for ALXN Europe
    • In cooperation with EU-QPPV prepares, manages, implements and follows up on PV inspections carried out by global regulators.

 

 

Qualifications

  • 2 to 4 years of experience in the Pharmaceutical Industry
  • Experience as Diagnostic Manager is a plus
  • Must have a minimum of 2- 5 years handling patients programs
  • Experience in Hematology/Nephrology is highly desirable.
  • Experience in orphan diseases is a plus.
  • Excellent knowledge of local and/or regional regulations and requirements for Pharmacovigilance
  • Strong knowledge of local pharmaceutical regulations and related ethic behaviors relating to regulatory, quality and PV activities
  • Strong knowledge of regulatory inspections with the ability to effectively handle all situations that may occur and determine appropriate strategies and courses of action
  • Solid background and experience in pharmaceutical quality system management (GxP)
  • Strong project management, interpersonal, communication and presentation skills
  • Fully bilingual English-Portuguese.

 

 

Education

  • Bachelor’s Degree in MD / Nurse required

 

Competencies

BE Alexion Competencies :

  • learning and self- development;
  • ensures accountability;
  • cultivates innovation;
  • being resilient;
  • decision quality;
  • collaborates

BE  Alexion Leader Competencies:

  • attracts and develops top talent;
  • drives results;
  • strategic mindset;
  • manages ambiguity and complexity;
  • optimizes work processes;
  • drives engagement

*LI-RM

 

Sao Paulo, Brazil
 

 

Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.