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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.
In 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.
Should you be interested in this position, please use the Linkedin link to apply with your CV.
Please note that we will only contact shortlisted applicants.
Disclaimer: Cheplapharm does not accept unsolicited CVs from recruiters or employment agencies in response to this posting.
Description of the function:
The Global Regulatory Affairs Manager will play a pivotal role in ensuring the efficacy, quality and safety of our pharmaceutical products.
The successful candidate will be responsible for overseeing the regulatory activities, managing various regulatory related processes, and ensuring compliance with regulatory requirements.
In this role, your tasks will include:
End-to-end support consisting of all activities related to Marketing Authorisation transfer (MAT) and lifecycle management of pharmaceutical products mainly in EU; that includes:
MAT: execute the regulatory strategy; plans, prepares and delivers high-quality regulatory files to agreed timelines; responsible for the post-submission/approval activities, such as batch release change, technical transfer.
Product lifecycle management of marketed products: responsible for the dossier compliance including CMC variations, timely regulatory filings and response to HA queries.
To that end:
Autonomously manage regulatory activities and overseeing the day-to-day operations within the regulatory department;
Monitor and keep abreast of the regulation and perform gap assessment as needed;
Interact effectively with various stakeholders within the company (labelling, pharmacovigilance, quality, medical, artworks, supply chain, commercial and affiliates) and external stakeholders such as Health Authorities, third service providers.
Contribution to the RA department as follows:
Develop, implement and update regulatory SOPs and other regulatory processes;
Provide regulatory training to internal teams and ensure staff are updated on the latest regulations and best practices, where applicable;
Participate in cross-functional team meetings to provide regulatory expertise;
Participate to RA audit and self-inspection.
Qualifications:
Master degree in Life science/Pharmaceutically-related science.
Minimum of 5+ years of experience in global regulatory within the pharmaceutical industry; versatile experience within CMC, project management and/or CRO is advantageous.
In-depth knowledge of global regulations and guidelines (FDA, EMA, ICH, national, etc.).
Experience in HA interactions.
Thorough knowledge of eCTD and CTD filing requirements, as well as global filing requirements.
In-depth knowledge of document management best practices.
Experience as Information Officer would be a plus.
Good planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders.
Excellent communication and interpersonal skills.
Ability to work independently and prioritize tasks in a fast-paced environment.
Experience in working in a matrix organization.
Proficiency in verbal and written English; knowledge of other languages is advantageous; good computer skill.
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 regulatory 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.
Should you be interested in this position, please use the LinkedIn link to apply with your CV.
Please note that we will only contact shortlisted applicants.
Disclaimer: Cheplapharm does not accept unsolicited CVs from recruiters or employment agencies in response to this posting.