For our customer, a smaller, worldwide active Life Sciences start-up group (focus on oncology) with a EU location in Rome (and other locations), we are seeking a Drug Safety Specialist / QPPV EU.

Responsibilities:

• Act as Qualified Person Responsible for Pharmacovigilance (QPPV), a business critical regulatory and safety governance role mandated by the EU with broad responsibilities as defined by EU laws, in order to obtain and maintain the Marketing Authorization of the group’s EU portfolio
• Represent the group towards governmental agencies and other authorities related to PV topics
• Establish, maintain and improve the group’s EU wide and global PV systems
• Responsible for handling routine tasks and leading targeted investigations and initiatives to further strengthen the PV system in order to maintain full QPPV oversight over the group’s PV
• Proactively monitor compliance as well as for gaps and initiate appropriate corrective and preventive actions
• Ensure awareness of new regulations and compliance with PV legislation within EU and global markets
• Ensure global inspection readiness at all PV sites through regular review of the PV (quality) system and take a risk-based approach when designing and implementing CAPAs
• Lead for targeted investigations and improvement initiatives
• Oversight over PV operations and PV systems and respective compliance
• Critically review benefit-risk evaluation, aggregate reports and planned risk management measures
• Contribute to and coordinate communications to the Regulatory Authorities relating to safety and PV matters and coordinate responses to any request from Regulatory Authorities for (further) information
• Closely cooperate with the group’s affiliates, regions and all other stakeholders in order to ensure compliance and inspection readiness
• Manage, at the Global Safety Review Team and Global Safety Committee, the Global Safety Governance system
• Keep up-to-date specific parts of the PV System Master File and ensure compliance
• Develop strategic risk management plans
• Review and approve PV relevant information in clinical study protocols
• Understand regulatory framework, trends & requirements related to products, clinical studies and global drug development
• Develop and review safety information as part of reports submitted to regulatory authorities
• Accountable for the safety monitoring strategy and reference safety information documents throughout a product’s lifecycle

Requirements:

• Medical Doctor with 3 years working experience as a physician
• At least 5 years industry experience within a global Pharmacovigilance function and in working across functional areas; advanced knowledge of standard business procedures
• Excellent knowledge of EU and other Pharmacovigilance legislations
• Fluent in English; German, French and/or Spanish would be a plus
• Strong relationship builder both internally and externally and strong communicator at all levels of the organization
• High ethical standards as well as personal credibility, the ability to gain trust at the most senior executive level, can speak forthrightly and encourage others to do the same
• Sound and balanced judgment; able to assess and handle risks; self-confident, proactive and decisive
• Able to work effectively and collaboratively across the organization
• Ability to influence and delegate
• Has the expertise, determination and courage to resolve or escalate issues as appropriate
• Good negotiating skills, tact, diplomacy
• Willingness to take up residence at one of the group’s EU locations in, e.g., Rome