ProClinical is excited to announce that a new job opportunity has arisen for a Senior Safety Physician to join a young and flourishing biotechnology company focused on late-stage drug pipelines and developing new treatment options for orphan diseases. Based in Copenhagen, the company's clinical trials have been very successful, and as a result, the company is in the process of moving into commercialisation.
The Senior Safety Physician will report to the Head of Clinical Safety and be responsible for benefit-risk assessments, surveillance activities, and safety-related deliverables for dedicated projects/products.
Working with the Head of Clinical Safety, the incumbent Senior Safety Physician will make recommendations to ensure that the company's clinical studies are handled in compliance with regulatory requirements and ensure that safety signals are handled appropriately. They will also help to ensure that the business has appropriate systems in place for pharmacovigilance, compliance, and product safety management.
The successful candidate will also provide guidance to key stakeholders in addressing issues related to clinical safety in the clinical trial programmes. They will also contribute to the growth of the clinical development strategy for dedicated projects/products.
If the company applies for MA, the role will extend to include acting as deputy to the EU Qualified Person for Pharmacovigilance (EU QPPV), providing support to the QPPV in undertaking her responsibilities.
Job Responsibilities:
- Being accountable 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.
- Providing medical input to safety assessments.
- Acting as ambassador for safety governance within and outside the company.
- Preparing and reviewing key regulatory documents and programs, such as PSURs, RMPs, PASS and CAPAs.
- Co-driving continuous improvement of the PV system and its performance.
- Overviewing safety profiles and emerging safety concerns.
- Maintaining an awareness of developments in the safety profiles of the products.
- Engaging with the relevant functions in the development, organisation, and reviewing of key regulatory documents related to clinical safety for dedicated projects/products.
- Staying abreast on the PV system in terms of organisation and performance.
- Overseeing and guiding 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.
Skills and Requirements:
- An MD as a Physician.
- At least five years of experience in pharmacovigilance, including strong knowledge of Global Pharmacovigilance, legislation, and regulations.
- Demonstrable experience with clinical development.
- A clear understanding of the processes associated with Safety, Regulatory, and Clinical Development.
- Good understanding of the operational aspects of PV.
- Demonstrable experience in providing deliverables for health authorities, including, but not limited to the US FDA, EMA, MHRA, is a desirable attribute.
- Willing to be part of interdisciplinary teams with a spirit of initiative and proactivity.
- Excellent English verbal and written communicative skills.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Pontus Larsson Zetterland on +44 203 319 3030 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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