A Career AT Orphazyme

Orphazyme is a development stage biopharmaceutical company. Our highly motivated and talented team of professionals is dedicated to the development of innovative therapeutic approaches to severe diseases, and cooperates with the research community worldwide.

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Current VacancIES

Senior Pharmacovigilance Specialist   

Orphazyme is looking for a Senior Pharmacovigilance Specialist to join our team and build our post-marketing pharmacovigilance system and ensure regulatory compliance. This is your opportunity to join a dedicated team of professionals and become an important part of Orphazyme’s Clinical Safety in a progressive and innovative biopharmaceutical company.

Orphazyme is a listed biotech company based in Copenhagen. We develop new treatment options for orphan protein-misfolding diseases (lysosomal storage and protein-aggregation diseases). Concurrently, we are interacting with regulatory authorities to plan for a marketing authorization application in the beginning of 2020 and we are therefore seeking a Senior Pharmacovigilance Specialist to lead the development of our post marketing pharmacovigilance system.

Your tasks:

The job will include the following main responsibilities:

·         Lead the development of a post marketing pharmacovigilance system ensuring regulatory compliance in processes and systems such as:

o    Designing processes for scientific evaluations and quality assurance in collaboration with the team and collaborators/service providers 

o    Setting key performance indicators

o    Ensuring QPPV oversight

o    Contribute to safety agreements

o    Be responsible for the PSMF

o    Development of training programs   

In addition, you will have an important role in ensuring continued marketing authorization of our compounds:

·         Performing safety surveillance activities

·         Supporting the QPPV in maintaining oversight

·         Maintain oversight of regulatory requirements

·         Provide operational support to the production of scientific reports (PSURs etc)

·         Ensuring appropriate training of the organisation

·         Collaboration with service providers

The position will report to the Head of Clinical Safety.

Profile:

·         Great interest in post marketing pharmacovigilance

·         You have at least 5 years of pharmacovigilance experience

·         You have a relevant scientific background

·         Good ability to take initiative, prioritize, multi-task, and work well under pressure to meet deadlines

·         You work independently

·         You are a team player

·         Ability to contribute to documents with consistency and attention to detail

·         Clear and systematic thinking that demonstrates good judgment and problem-solving competencies

·         Good written and oral communication skills

·         Well organized and structured

·         Ability to drive projects and deliver results

·         Good understanding of global pharmacovigilance requirements and experience in interpretation of the legislation

·         Willing to be part of interdisciplinary teams with spirit of initiative and proactivity

We can offer you:
To be part of a small company and a pharmacovigilance department that is developing each day. Orphazyme has an exciting pipeline and a collaborative working environment.

Application
Please apply by sending an email marked “Senior Pharmacovigilance Specialist” with your application and CV to career@orphazyme.com. If you have questions about the position, you are welcome to contact Head of Clinical Safety, Marie Aavang Geist at +45 3144 3136.

Our company offers exciting and meaningful career opportunities in an adaptable work environment. We are looking for new colleagues to join our team on the journey towards bringing life-changing therapies to patients who have no satisfactory treatment options today. 

We encourage anyone interested in a job to apply, irrespective of gender, age, race, religion, or ethnicity.

Deadline
We will conduct interviews on an ongoing basis, but final deadline is June 30, 2019. Planned start August 1, 2019

Senior Quality Assurance Manager

Are you our new colleague? This is your opportunity to join a dedicated team of professionals and become an important part of the Quality Assurance department of a progressive and innovative biopharmaceutical company. We seek a Senior Quality Assurance Manager to support our quality compliance activities.

As Senior Quality Assurance Manager at Orphazyme, you will become an important part of the Quality Assurance function in a Danish biopharmaceutical company with a late-stage pipeline. In the position, you will have direct report to the Head of Quality Assurance.

The position is newly-established and you will have the opportunity to influence  the expansion and strengthening of the QA function in Orphazyme.

Your main tasks are:

·      QA support to operational functions within Orphazyme

·      Lead Auditor – plan, perform, report, and follow up on internal and external audits:

- Clinical investigator sites

- CROs (clinical and non-clinical)

- Laboratories (clinical/bioanalytical)

- Internal audits at Orphazyme, including IT systems

·      Ensure assessment, selection, approval, oversight, and final evaluation of vendors performing GXP activities within area of responsibility

·      Quality Management System – authoring, reviewing, and administrating quality documents

·      Management of quality incidents, including CAPAs

·      Training – organizing and executing training of Orphazyme employees, e.g. in GCP

·      In collaboration with functional departments, ensure inspection readiness

·      Identify and contribute to areas of best practice and continuous process improvements across the organization

Your qualifications include 8+ years of broad experience within Quality Assurance in the pharmaceutical industry, including GCP and GLP. Experience in auditing clinical investigator sites, clinical/non-clinical CROs, and clinical and bioanalytical laboratories is a prerequisite. Knowledge of evaluation and auditing of computerized systems is a strong asset. Ideally, you have hands-on experience in coordinating and hosting inspections by regulatory authorities (FDA/EMA). Knowledge of Data Protection legislation would be an additional asset.

You have an M.Sc. within life sciences or similar.

As a person you are:

·      Assertive

·      Pragmatic

·      Diplomatic

·      Independent

·      Self-motivating

Importantly, you are able to communicate clearly in English, both verbally and in writing.

The position will have a high level of exposure, and you must be able to work collaboratively across multiple functions within the organization.

As the right candidate for this position, you will bring a blend of QA experience and an adaptive mindset allowing you to grow into a role which may develop over time in line with the development of the company.

Travelling: Approx. 15-30 days per year.

Domicile: Central Copenhagen

Application Please apply by sending an email marked “Senior Quality Assurance Manager” with your application and CV to career@orphazyme.com . If you have questions about the position, you are welcome to contact Head of Quality Assurance, Poul Manniche at +45 3118 9950.

We encourage anyone interested in the job to apply, irrespective of gender, age, race, religion, or ethnicity.

Deadline: Applications will be reviewed on an on-going basis.

Our company offers exciting and meaningful career opportunities in an adaptable work environment. We are looking for new colleagues to join our team on the journey towards bringing life-changing therapies to patients who have no satisfactory treatment options today. 

We encourage anyone interested in a job to apply, irrespective of gender, age, race, religion, or ethnicity.

Senior Drug Safety Physician

The Senior Drug Safety Physician, reporting to the Head of Clinical Safety, will be responsible for benefit-risk assessments, surveillance activities, and safety-related deliverables for dedicated projects/products.

The candidate will support the Head of Clinical Safety in making recommendations to ensure that Orphazyme’s clinical studies are handled in compliance with regulatory requirements, and in ensuring that safety signals are handled appropriately. He/she will also help to ensure that the business has appropriate systems in place for pharmacovigilance compliance and product safety management.

The person will be part of clinical trial teams and cross-functional Safety Committees and work collaboratively with other departments (such as Clinical Science, Medical Affairs, Clinical Operations, Regulatory Affairs, Quality Management, and Nonclinical Safety) within the business, to address and resolve issues relating to development projects and processes.

The person will provide guidance to key stakeholders in addressing issues related to clinical safety in the clinical trial programs.

She/he will contribute to the evolvement of the clinical development strategy for dedicated projects/products.

If/when Orphazyme applies for MA, the role will extend to a role as deputy to the EU Qualified Person for Pharmacovigilance (EU QPPV), thereby providing support to the QPPV in undertaking her responsibilities.

Your tasks:

·       Responsible for benefit-risk assessments, surveillance activities, and safety-related deliverables including but not limited to Risk Management Plans, aggregate safety reports, safety sections of labelling documents, investigator brochures, relevant aspects of clinical study reports and submission dossiers for dedicated projects/products

·       Medical input to safety assessments

·       Act as ambassador for safety governance within and outside the company

·       Involvement in the preparation of review of key regulatory documents and programs, such as PSURs, RMPs, PASS, and CAPAs

·       Co-drive continuous improvement of the PV system and its performance

·       Overview of safety profiles and emerging safety concerns

·       Maintain an awareness of developments in the safety profiles of the products

·       Engage with the relevant functions in the development and review of key regulatory documents related to PV for products

·       Stay abreast on the PV system in terms of organization and performance

Profile:

·       MD Physician

·       At least 5 years of experience in pharmacovigilance including strong knowledge of Global Pharmacovigilance legislation and regulations

·       Experience with clinical development

·       Understanding of the processes associated with Safety, Regulatory, and Clinical Development

·       Oversee and guide the active monitoring through systematic signal detection and critical review of aggregate safety data and literature during all phases of clinical development and the life-cycle for all products/projects

·       Good understanding of PV operational aspects

·       Willing to be a part of interdisciplinary teams with spirit of initiative and proactivity

·       Experience providing deliverables for health authorities (including but not limited to the US FDA, EMA, MHRA) is preferred

·       Excellence in written and spoken English

·       In the future: Be available as a back-up to the EU QPPV

Application

Please apply by sending an email marked “Senior Drug Safety Physician” with your application and CV to career@orphazyme.com. If you have questions about the position, you are welcome to contact Head of Clinical Safety, Marie Aavang Geist at +45 3144 3136.

Deadline

Interviews will be held as applications are received.

Our company offers exciting and meaningful career opportunities in an adaptable work environment. We are looking for new colleagues to join our team on the journey towards bringing life-changing therapies to patients who have no satisfactory treatment options today. 

We encourage anyone interested in a job to apply, irrespective of gender, age, race, religion, or ethnicity.

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