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10 часов назад

GRAPS Patient Safety Operations, Post Marketing Manager (Pharmacovigilance)

46 000
Формат работы
hybrid
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Italy
Релокация
Italy
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TL;DR

GRAPS Patient Safety Operations, Post Marketing Manager (Pharmacovigilance): Leading post-marketing pharmacovigilance operations across a global portfolio with an accent on safety data integrity, regulatory compliance, and vendor oversight. Focus on ensuring GVP compliance, managing data collection from diverse sources, and preparing for global audits and inspections.

Location: Hybrid in Parma, Italy

Salary: From €46,000

Company

An international research-focused biopharmaceutical group operating in more than 30 countries.

What you will do

  • Lead post-marketing pharmacovigilance operations to safeguard patient safety worldwide.
  • Ensure high-quality, compliant collection and delivery of safety data to agencies.
  • Provide oversight for scientific literature evaluation and social media monitoring.
  • Manage relationships and data reconciliations with affiliates, CROs, and PV service providers.
  • Serve as the subject-matter expert for GVP audits, inspections, and CAPA implementation.
  • Drive continuous improvement and operational excellence within global Patient Safety processes.

Requirements

  • Degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or a related field.
  • Solid experience in Pharmacovigilance Operations within pharma or healthcare.
  • Strong knowledge of global PV regulations and GVP requirements.
  • Experience managing safety data collection and ensuring timely reporting.
  • Ability to work with cross-functional international stakeholders and external vendors.
  • Professional proficiency in English (written and spoken)

Nice to have

  • Advanced knowledge of ODCS and literature monitoring.
  • Experience with medical device and combination product vigilance.
  • Knowledge of safety agreements and CRO governance.
  • Project or change management experience in regulated environments.

Culture & Benefits

  • Competitive salary with an annual performance bonus scheme.
  • Comprehensive healthcare, pension, and private medical insurance.
  • Flexible hybrid working arrangements.
  • Wellbeing and flexible benefits programs.
  • Robust relocation support and tax assistance for foreign colleagues.

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