Pharmacovigilance Director/Drug Safety

Employer
Pharmascience
Location
Sofia (BG)
Salary
according to experience, with benefits + bonus
Closing date
14 Oct 2020

View more

Discipline
Clinical Research, Clinical Development, Drug Safety, Pharmacovigilance
Hours
Full Time
Contract Type
Permanent
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Pharmascience International is a division of Pharmascience Inc., a full-service pharmaceutical company, leading manufacturer and marketer of prescription; generic, over-the-counter, and behind-the-counter products with strong roots in Canada and a growing global reach. We develop and deliver top-quality products to patients and healthcare professionals in more than 60 countries across the world. 

As the Pharmacovigilance Director, your role will be to establish and maintain the European Pharmacovigilance system for Pharmascience products.

 

Responsibilities

  • Oversee and manage the Pharmascience European pharmacovigilance (PV) systems for EU and non-EU countries in countries in which Pharmascience products are marketed
  • Ensure proper Pharmacovigilance Agreements are in place with 3rd party suppliers and distributors in various countries in Europe as required
  • Develop and maintain the PV System Master Files (PSMF) ensuring that they are accurate and up-to-date descriptions of the various systems in place to undertake all pharmacovigilance obligations
  • Provide oversight for all functions related to the PV system for all Pharmascience products approved in European countries (EU and non-EU)
  • Provide medical input into Risk Minimization Measures (RMM) and Risk Management Plans (RMP) using own knowledge as well as consultations with medically trained colleagues as applicable
  • Ensure that the conduct of all PV activities and submissions of all PV related documents are in accordance with relevant legal requirements and Good Pharmacovigilance Practice (GVP) in the respective countries and territories
  • Ensure that full and prompt responses to any requests from the relevant competent health authorities is provided as required to allow for the benefit/risk evaluation of the medicinal products
  • Act as a single point of contact for the respective competent health authorities in EU member states and non-EU states
  • Promote, maintain and improve compliance with PV legal requirements and maintain up-to-date knowledge of PV regulations
  • Ensure back-up procedures are appropriately maintained and tested including for PV business continuity, Disaster Recovery and having in place a Deputy QPPV
  • Ensure procedures are in place for the effective cooperation with QC/QA functions within the Pharmascience organization with regards to product Health Hazard Assessments, product recalls, and the identification and investigation of product quality problems as they relate to product safety issues
  • Approve procedures, notices of change, Corrective Actions/Preventative Actions (CAPA), deviations and extensions
  • Participate in regulatory and client audits. Act as Pharmacovigilance SME
  • Approve validation protocols
  • Support the internal audit program

Qualifications

  • Bachelor's degree in Pharmacovigilance or related
  • Minimum of 10 years of experience in the European pharmaceutical industry in Pharmacovigilance. In addition, experience in Medical Affairs, Regulatory Affairs or Clinical Development would be an asset.
  • Good working knowledge of verbal and written English in a business and scientific setting is required
  • Familiarity with product development and product launch execution procedures
  • Familiarity with product strategy development and execution
  • Substantial expertise in Pharmacovigilance
  • Substantial experience in a global operations setting
  • Proficiency in interaction with opinion leaders and key external customers
  • Thorough knowledge of European regulatory requirements related to Pharmacovigilance
  • Strong knowledge about International policies, initiatives and regulations in terms of AE reporting and associated PV activities
  • Quality focus with good knowledge of relevant GVP regulations
  • Autonomous and able to plan, organize and manage multiple projects
  • Excellent interpersonal as well as oral and written communication skills
  • Prior experience with ARISg PV systems/databases is an asset

 

To learn more about our company, visit our website
https://www.pharmascienceinternational.com/

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