Lieu: Switzerland - Glattbrugg/Zurich

Fonction: Drug Safety/Pharmacovigilance

Compagnie: Vifor Pharma

Kira Maurer

Junior Talent Acquisition

+41 58 851 83 48

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Votre profil

We are currently looking for a Clinical Drug Safety Lead to join our Global Drug Safety and Risk Management Team. Reporting directly to the Head of Clinical Drug Safety, you will be responsible to ensure compliance of company drug safety. Your tasks and responsibilities will include, but not be limited to, the following:

  • Responsible for products in Clinical Development (Phase 1 to 3)
  • Providing medical support to Clinical Drug Safety Unit
  • Ensure and support the timely set-up, maintenance and close out of clinical interventional studies from a drug safety perspective
  • Being involved in the selection process of Contract Research Organisation(s) (CRO) and continuous monitoring of the progress of clinical studies from a drug safety perspective
  • Manage the review of worldwide reports on (serious) adverse events and suspected unexpected serious adverse reactions (SUSAR), including confirming company expectedness and causality assessments in the company’s Drug Safety/Pharmacovigilance Database
  • Ensure safety tasks in clinical studies are handled appropriately and in compliance with regulations (incl. management and review of Study Protocol and Investigator’s Brochure, Case Report Form, SUSAR, Aggregate Safety Reports, Informed Consent Forms, Statistical Analysis Plan, Medical Monitoring and Review Plan, as well as involvement in expedited safety reporting, Data and Safety Monitoring Boards, Trial Master Filing; Investigator Meetings)
  • As Clinical Drug Safety Subject Matter Expert, develop and maintain collaborations with cross-functional Clinical Study Teams and Benefit-Risk Teams
  • Close interaction with Drug Safety counterparts from CROs as well as Co-developmental Partners
  • Support the Global Regulatory Affairs department with evaluation of adverse event profile of product to update regulatory documents
  • Providing support in Audits and Inspections
  • Provide support in checking or preparing safety/medical expert reports as appropriate and preparing safety regulatory files
  • Involved in signal detection and Benefit/Risk evaluation including initiating appropriate measures e.g. preparing Drug Safety Board presentations, change control of Company Core Safety Information/ Company Core Data Sheets updating risk management plans and resulting actions plans
  • Being involved in creation and revision of (development) Risk Management Plans as well as Development Safety Update Reports
  • Active involvement in other safety studies (e.g. Post-Authorisation Safety/Efficacy Studies)
  • Creation of Medical/ Drug Safety related SOPs
  • Support Drug Safety trainings for new company staff, Pharmacovigilance staff as well as refreshers

The ideal candidate holds an academic degree with following additional experiences:

  • Preferable, holding a degree as M.D.
  • And/Or degree from a Para-medical education (e.g. nurse, pharmacist)
  • And/Or PhD in Life Science/Equivalent with experience in International Drug Safety, ideally operational as well as clinical drug safety
  • Experience in data analysis, signal detection and benefit/risk evaluation
  • Excellent knowledge of international regulations (ICH, GVP, EU Clinical Trial Regulations, FDA regulations)
  • Fluency in English
  • Experience in Pharmaceutical Medicine, particularly Clinical Research, and/or experience in Clinical Pharmacology
  • Knowledge/Experience in Pharmacoepidemiology is a plus
  • Minimum of 1-3 years of working experience in a CRO (Drug Safety, Trial/ Medical Monitoring) or in a Pharmaceutical Company in Clinical Trial related environment (Clinical Research/ Development, Drug Safety)
  • Headquarter experience is a plus
  • Demonstrated ability to set up and implement drug safety strategies, risk management plans, develop Clinical Drug Safety systems and procedures
  • Demonstrated proficiency in problem-solving with respect to pharmaceutical Drug Safety issues
  • Good computer literacy with experience with safety data bases (ARISg preferably)
  • Capable of exercising oversight in communications and problem solving liaisons with internal and external customers
  • Capable of exercising oversight in the understanding and maintaining of Drug Safety issues with internal and external Clinical team members and ensure appropriate training through workshops, seminars, courses, literature or other means consistent with Drug Safety development

You bring very good scientific, pharmaceutical and medical knowledge. Your attitude and entrepreneurial spirit is congruent with the company values. You take a thorough approach with high attention to detail and can think and influence conceptually, strategically and rationally. You are interpersonally aware and culturally sensitive, with the ability to work in highly networked organisations with many partners. You have excellent verbal and written communication skills. You are effectively able to plan and prioritise workload, with an accurate sense of urgency. You are able to interpret and apply global drug safety regulations and demonstrate a proactive attitude.

A propos de nous

Le Groupe Vifor Pharma, anciennement Groupe Galenica, est une entreprise Specialty Pharma mondiale qui se consacre à la recherche, au développement, à la fabrication et à la commercialisation de ses propres produits pharmaceutiques. Il est le partenaire de choix pour les solutions innovantes axées sur le patient. L’entreprise, qui entend devenir le leader mondial des traitements de la carence en fer et des affections néphrologiques et cardio-rénales, aspire à aider les patients du monde entier souffrant de maladies graves et chroniques à mener une vie meilleure et plus saine. Le Groupe Vifor Pharma possède des sites de production en Suisse et au Portugal, ainsi qu’un réseau dynamique de sociétés affiliées et de partenaires lui assurant une vaste couverture de marché dans le monde entier. L’entreprise affiche une présence mondiale en constante augmentation mais conserve de solides racines dans son marché d’origine, la Suisse.

Le Groupe Vifor Pharma est constitué de Vifor Pharma, de Vifor Fresenius Medical Care Renal Pharma – sa société commune avec Fresenius Medical Care –, de Relypsa et d’OM Pharma.

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Conditions pour les agences de placement