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Pharmacovigilance Scientist

Date: Jun 8, 2021

Location: Madrid, ES, 28108

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Long Description

  • Monitoring of the ES drug safety mailbox.
  • Perform case registration of adverse events and special situation reports from clinical trials as well as from post marketing sources (for example: PSPs, local literature search, etc.) by entering searchable information and performing duplication checks (maintaining a high quality of data management).
  • Responsible for seriousness triaging of adverse event information.
  • Responsible for sending adverse event information to in license partners within the required timeline as per pharmacovigilance agreement.
  • Responsible for collecting additional information from reporters and performing follow-up with health care professionals and/or consumers.
  • Perform periodic reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements, as well as source documents received from other internal departments when required.
  • Participate in the ES Pharmacovigilance audits and inspections as needed.
  • Responsible for drafting, reviewing and finalizing CAPAs as needed for late submissions and non-compliance with internal processes
  • Responsible to complete all training and SOP/WI reviews in a timely manner.
  • Solves complex problems; takes a new perspective using existing solutions.
  • Works autonomously within established procedures, practices and legislation.
  • Perform a process of control, review, comparison and maintenance of the management process at the local level of CCSIs (Company Core Safety Information) ensuring that all safety information is implemented and updated in the technical data sheets.
  • Collaborate in the process of elaboration and control of local PhV procedures.
  • Collaborate in the process of elaboration and control of local aRMMs.
  • Actively collaborate during the Pharmacovigilance training process to all Teva Spain employees preparing, developing, training and recording all the activity that is required according to the job position of each employee.
  • Leading different projects and other tasks as assigned by LSO.
  • Must possess interpersonal, decision-making, and organizational skills.
  • Should serve as a liaison with other Teva business units and function such as Regulatory Affairs, Portfolio, Business Development, Strategic planning, Industrial Business, Legal Department, Medical Affairs / Medical Information Quality Assurance S&M, Sales Force, Marketing, Customer Service, Communication and Supply Chain.
  • Should serve as a liaison with other External stakeholder such as Healthcare professional, patients, national Competent Authorities, Service Provider and other 3rd Parties.

Qualifications

  • Bachelor's degree in life sciences / pharmaceutics / nursing / biology / veterinary medicine.
  • Master’s Degree in pharmaceutical industry.
  • Spanish mother tongue.
  • Fluency in both written and spoken English.
  • Other local languages’ knowledge are taking into account.
  • Proven experience in Healthcare or pharmaceutical industry and PhV experience will be taken into account.
  • Demonstrates proficiency with Microsoft Office, Excel and PowerPoint.
  • Comfort with PHV IT systems and a familiarity with DELTA, Cognos, Arisg, TrackWise, Insight and Glorya.

Function

Regulatory Affairs

Sub Function

Pharmacovigilance

Reports To

In process of validation

Already Working @TEVA?

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.