Director, EU QPPV

at  Apellis Pharmaceuticals

Please note that we are currently not accepting applications from recruitment agencies or engaging in recruiting agency partnerships for this role. We kindly request that agencies refrain from contacting our business or business leaders directly. Direct applications from candidates are welcome.

POSITION SUMMARY:

The EU QPPV is responsible for the establishment and maintenance of the pharmacovigilance (PV) system and ensuring the system is compliant with EU regulations and other applicable local regulations and guidelines (e.g., EU GVP). The EU QPPV will maintain a thorough understanding of the safety profiles of medicinal products in the Apellis portfolio under assessment or authorised in European countries. The EU QPPV will act as a point of contact for EMA and other regulatory authorities, as needed, and will interact with the authorities regarding the safety of the products. The EU QPPV will review, approve, and/or oversee the PSMF, RMPs, risk minimisation measures, PASS studies, global and local procedures, Safety Data Exchange Agreements, and audit reports.
The EU QPPV will participate in relevant meetings and committees and will have extensive cross-functional interactions across the organization. The EU QPPV will lead and support the local EU PV representatives and Deputy EU QPPV and may serve as line manager. The EU QPPV may act as regional/local PV responsible person in applicable European countries (e.g., Germany, UK).

EDUCATION, REGISTRATION & CERTIFICATION:

• Healthcare professional, physician highly preferred

EXPERIENCE:

• At least 10 years prior experience in PV, preferably in Germany and other ex-US markets
• Experience interacting with EMA and other regulatory authorities
• Experience with commercial and clinical lifecycle phases is desirable

SKILLS, KNOWLEDGE & ABILITIES:

• In-depth knowledge of PV regulations and guidelines especially with regards to Europe
• Demonstrated understanding of the safety database
• Superior written and oral communication skills and the ability to influence and work effectively with different levels of management across departments
• Highly motivated with the ability to be flexible in a fast-paced environment
• Comfortable working independently with supervision
  Ability to communicate in English and German, at business level

KEY RESPONSIBILITIES INCLUDE:

• Working with cross-functional global and local teams to establish efficient and compliant safety data handling and post-marketing surveillance processes and procedures, focusing on the European region
• Ensuring ongoing conduct of PV activities, including submission of PV-related documents, is in accordance with regulations and guidelines
• Maintaining awareness of safety concerns, marketing authorisation conditions and commitments, safety-related variations, and safety communications to patients and HCPs
• Supporting and mentoring local PV representatives and ensuring local activities are aligned with regional and global standards
• Supporting the due diligence and oversight of PV service providers and business partners
• Assisting in safety review (signal assessment) and aggregate report generation
• Maintaining the PSMF, ensuring regular review cycles
• Partnering with Quality to lead inspection readiness, inspection/audit execution, and CAPA management
• Acting as contact point for authorities for safety-related communications and coordinating safety-relevant responses from various stakeholders
• Overseeing risk management/minimisation activities and contributing to benefit-risk evaluations
• Maintaining a comprehensive PV regulatory intelligence management process in Europe
• Supporting the safety processes for clinical development in Europe
• Maintaining Apellis data in Eudravigilance
• Availability 24/7 as PV contact for regulatory authorities

OTHER DUTIES:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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