EU-QPPV (f/m/d) - Pharmaceutical Safety Expert

vor 1 Monat

Wien, Wien, Österreich ISG Personalmanagement GmbH Vollzeit
Job Description:

The successful candidate will be responsible for managing post-marketing PV/safety responsibilities for an internationally active, well-established pharma SME. Key functions include formal EU-QPPV and Head of PV Management roles, with responsibilities according to Regulation (EC) No 726/2004 Articles 23ff.


Responsibilities:

  • Establish and maintain the PV system, including rRMMs, and prepare PV reports as defined by regulations.
  • Represent the group at audits, inspections, and response processes to post-marketing PV matters.
  • Act as a point of contact for regulatory authorities and PV inspections.
  • Manage ICSR reporting and aggregate reports, focusing on accuracy, completeness, and timeliness.
  • Ensure safety databases are managed, and personnel are trained in relation to PV.
  • Provide safety contributions to regulatory authority submissions.
  • Manage (potential) AEs, including monitoring relevant literature in cooperation with local PV managers and external partners.
  • Conduct safety assessments and drug safety reports for signals or other issues.

Requirements:

  • MD preferred or advanced science degree in Life Sciences required.
  • High level of experience and expertise in PV in the EU, including medical safety.
  • Excellent knowledge of European regulatory requirements relating to PV.
  • PV systems experience, including compliance, databases, procedures, QA, and training.
  • Experience with audits/inspections.
  • Fluent English proficiency (C2), further EU language skills an advantage.
  • Highly reliable, communicative, and entrepreneurial personality.

The Offer:

The company offers a fixed monthly gross salary at a minimum of EUR 5.000.--, with possible overpay depending on qualification, experience, and local standards.


How to Apply:

Please send your application, including CV and motivation letter, under Kennnummer 104 105, preferably on our application portal ISG-Karriereportal or per eMail to bewerbung.seligo@isg.com.

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