Senior Director, EU QPPV and Head of Pharmacovigilance Operations

Pharmacovigilance Munich, Germany


Description

Position Summary:

The Senior Director is a key member of our Pharmacovigilance team and is responsible for global PV operations, drug safety systems and leadership of European safety activities. As EU QPPV this role will be Apellis’ interface for safety matters with the European regulatory authorities. He/she will also be responsible for the company’s compliance with global PV reporting regulations and the PV quality system. This role will also be responsible for drug safety systems and supporting the European leadership team.

Key Responsibilities Include:

  • Fulfil the QPPV legal requirements and oversee global PV reporting compliance, PV quality assurance, the postmarketing signal management process and related safety systems
  • Implement changes to standard procedures and ensure that processes and their documentation are fit for purpose
  • Maintain PV inspection readiness with respect to records, procedures and systems. Lead corrective actions in response to inspection findings
  • Oversee PV services vendors, and participate in search and selection activity
  • Lead the production and maintenance of the PSMF, EU-RMP and safety sections of the SPC
  • Maintain compliance with EudraVigilance industry user requirements
  • Collaborate with the VP, European Medical Affairs to ensure that post-authorisation safety studies are delivered to time and quality
  • Review and approve the PBRER  
  • Recruit, supervise and develop PV Operations team members
  • Member of Apellis’ medical governance committee
  • Support the European leadership team with PV expertise
  • Ensure that PV/safety data exchange agreements are created and maintained with business partners
  • Supervise or oversee the UK QPPV
  • Act as deputy for the VP, Safety & Pharmacovigilance
  • Other duties as assigned.

Education, Registration & Certification:

  • MD or PhD required

Experience:

  • At least 12 years of industry pharmacovigilance experience required, including PV operations leadership 
  • Thorough knowledge of GVP, ICH and EMA guidelines on PV is required
  • Prior EU QPPV/deputy QPPV experience is an advantage
  • Drug safety systems management experience is an advantage

Skills, Knowledge & Abilities:

  • Comfortable working independently with minimal supervision 
  • Strong management capabilities with a proven record as a functional leader
  • Highly organized, results driven, problem solver with a global outlook
  • Superior written and oral communication skills in English and German, and the ability to work with different levels of management 
  • Extensive knowledge of MedDRA and PV databases
  • Highly motivated with the ability to be flexible in a fast-paced environment 
  • EudraVigilance EVDAS/XEVMPD training is an advantage
  • Regional and international travel will be required: up to 20%

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.