Qualified Person for Pharmacovigilance
vor 3 Wochen
Description of the function:
The QPPV will be responsible for overseeing the pharmacovigilance system, ensuring compliance with EEA regulations, and serving as a key point of contact for regulatory authorities, ensuring the safety and efficacy of our pharmaceutical products.
The ideal candidate will have a deep understanding of pharmacovigilance systems and processes, Risk Management Plans (RMPs) and possess excellent communication skills in both English and German.
AufgabenIn this role, your tasks will include:
- Act as the Qualified Person for Pharmacovigilance (QPPV) as required by European legislation, ensuring the company’s pharmacovigilance system is compliant with relevant regulations
- Perform tasks of the Graduated Plan Officer (Stufenplanbeauftragte) including those under section 19 AMWHV
- Proven experience in reviewing and overseeing the preparation of Periodic Safety Update Reports (PSURs), PBRERs and Risk Management Plans (RMPs), ensuring high-quality documentation and data integrity
- Maintain a thorough understanding of RMPs, staying updated with current practices and regulatory expectations
- Support health authority inspections and audits, ensuring readiness and compliance across all aspects of pharmacovigilance.
- Develop and maintain pharmacovigilance systems and processes in compliance with global regulatory requirements
- Collaborate with cross-functional teams to implement pharmacovigilance strategies and ensure effective risk management
- Provide pharmacovigilance expertise and guidance to internal teams, stakeholders, and external partners. Liaise with Health Authorities, external partners, and internal stakeholders on pharmacovigilance-related matters
- Provide pharmacovigilance and product training to internal teams and ensure staff are updated on the latest regulations and best practices
- Review and contribute to various safety related documents from a PV perspective
- Develop, implement and update PV SOPs and PV processes during company growth phase
Qualifications:
- Relevant Life Science degree (Medical, Pharmacy, Nursing or equivalent)
- Prior QPPV experience would be considered an advantage. However, minimum of 10+ years of experience in pharmacovigilance, demonstrating a comprehensive skill set akin to a senior PV professional. The ideal applicant will possess extensive knowledge and expertise in drug safety, risk management and regulatory compliance.
- In-depth knowledge of EMA pharmacovigilance regulations and guidelines, others an advantage
- Proven experience in reviewing PSURs, PBRERs, DSURs and RMPs. Strong understanding of RMPs and pharmacovigilance regulatory requirements
- Experience supporting health authority inspections and knowledge of inspection processes
- Team management skills, strong logical, critical and problem-solving abilities
- Fluent in English and German with excellent communication and interpersonal skills, and the ability to interact effectively with cross-functional teams
- Desirable: Experience in conducting and managing audits within the pharmacovigilance domain.
We offer:
- A unique opportunity to work in a lean and fast paced company where you will be able to provide significant input to the pharmacovigilance department
- A full time position
- A competitive remuneration
- A dynamic and modern work environment
- Hybrid working environment, with a minimum of 2 days/week in company office in Lörrach, Germany
CHEPLAPHARM is a family-owned company headquartered in Greifswald, Germany. For more than 20 years, the company has been very successful in taking over well-known and well-established medicines from the research-based pharmaceutical industry and transferring them to an existing global network of partners for manufacturing and distribution. In this way, CHEPLAPHARM ensures the continuous supply of these medicines to patients worldwide. In addition to its headquarters in Greifswald, CHEPLAPHARM operates further sites in France, Japan, Russia and Switzerland. The company employs around 650 people worldwide.
The affiliates in Switzerland and Lörrach, Germany were established in 2023 to further drive the growth of the group and global acquisitions of established medicines from large pharmaceutical companies.
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