Director, QPPV – EU
Location: Berlin, Germany
Department: Drug Safety & Pharmacovigilance
Headquartered in Emeryville, CA, Zogenix is a biopharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases.
We are currently looking to hire a Director, QPPV to cover UK and EU. This is an exciting opportunity to join the European Medical Affairs function at Zogenix and to support the European launch of the company’s first commercial product along with providing support for other business objectives. The Director, QPPV role will help Zogenix establish a high performing Pharmacovigilance organization. The role will report into the VP, Safety & Pharmacovigilance who is based in Emeryville.
The QPPV will be based remotely in either Germany or France. #LI-Remote
- To influence the performance of the pharmacovigilance system. The MAH shall ensure that the QPPV has sufficient authority to influence the performance of the quality system and pharmacovigilance activities of the MAH.
- Development and maintenance of the Master file of the pharmacovigilance system (PSMF), overseeing its content and maintenance, and ensuring the availability of the PSMF to Competent Authorities (CA).
- Is the Primary Company contact for EMA and EU country competent authorities on a 24/7 basis, for issues involving the safety of the company’s products and ensures that the back-up is available and fully informed about current drug safety issues in case of their absence.
- Ensuring that any delegation of specific tasks to appropriately qualified and trained individuals is documented.
- Oversight and maintenance of the Quality Management System related to pharmacovigilance, including management of Standard Operating Procedures (SOPs), associated Work Instructions (WIs) and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed to ensure alignment with global SOPs.
- Ensuring timely management of deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate.
- Management of the PV compliance and audit function to ensure compliance from internal stakeholders and external business partners with legal requirements.
- Responsible and accountable for conduct of continuous overall pharmacovigilance evaluation of the company’s products authorized in the EU. Maintains an overview of the benefit risk profile and any emerging safety concerns and has an obligation to inform the Competent Authorities, when a public health concern is identified.
- Responsible and accountable for compliance of expedited and periodic reporting as well as the quality of the reports (ICSRs, PSURs, reports on company-sponsored post-authorization safety studies) to be submitted to the EU Competent Authorities.
- Ensures full, prompt and accurate response to any request from the EU Competent Authorities and notification of emerging safety issues.
- Is the contact for Pharmacovigilance Inspections which are conducted in the EU.
- Responsible for establishing and maintaining all QPPV governance procedures and mechanisms to allow the sponsor’s QPPV Network to always meet mandated regulatory obligations world-wide.
- Supporting the head of global safety to oversee and implement appropriate affiliate PV processes and compliance monitoring
- Maintains understanding of and ensures compliance of SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.
- Participates in audits/inspections and ensures inspection readiness at all times. Participates in quality investigations and implementation of corrective and preventative actions.
- Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug safety, pharmacovigilance and product registration.
- Train Zogenix colleagues about regulations and guidance.
- Other duties as assigned.
Knowledge, Experience & Skills
- MD qualified an advantage, but not essential
- 7+ years of experience in pharmaceutical industry, preferably neuroscience and/or epilepsy and/or rare diseases
- Strong background as a QPPV on a European level
- Broad understanding of healthcare delivery environment, and the role of the pharmaceutical industry
- Comprehensive understanding of Industry Medical and Financial governance norms, with reference to compliance with all European laws, regulations, and codes of scientific and promotional Practice
- Effective collaboration across cross-functional and geographical boundaries
- Demonstrated leadership ability
- Proven flexibility and adaptability with cultural astuteness and sensitivity
- High ethical standards and able to work with transparency and Openness
- Sound organizational skills to manage multiple projects simultaneously
- Strong written and verbal communication skills along with excellent judgment and ability to work in a team environment
- Proven ability to work across a cross-functional matrix
- Self-starter with “can do” attitude
- Knowledge of budget and account management
- Able to travel to domestic and International conferences
- Regular travel to European Headquarters in Maidenhead, UK is required
- Fluency in English is required. Other languages a plus.