PV Specialist with passion for Patient Safety
Are you looking for an opportunity to utilize your advanced PV knowledge, clinical expertise and dedication to patient safety?
Lundbeck Global Patient Safety is a dynamic cross functional department that is driven by a passion for patient safety. We are continuously striving to do the best for our patients by ensuring our processes are of high quality and consistent with regulatory requirements. We are also dedicated to doing the best for our employees with strong focus on professional development in a supportive environment, respecting work-life balance and providing home/office flexibility.
We are currently seeking a new colleague with solid background in pharmacovigilance and robust experience with clinical trial conduct who thrives in being a key resource for the team. Are you familiar with international regulatory requirements governing drug safety, especially in relation to clinical trial activities? Do you like to be a driving force in devising, implementing and optimizing drug safety processes in compliance with global regulatory requirements and in accordance with Global Patient Safety´s strategic framework to be premier leaders in global PV? Do you want to cooperate with stakeholders across the organization? Then this may be the job for you. The position is in our Global Patient Safety Data Management department located at Lundbeck’s headquarters in Copenhagen. We collaborate closely with the other key sites for Global Patient Safety in Chicago and Singapore.
Global Patient Safety, Data Management
As a patient-centric function within Research and Development, Global Patient Safety is responsible for the safety surveillance and benefit-risk assessment of all Lundbeck’s pharmaceutical products, including pipeline and established products. We consist of more than 90 dedicated colleagues who strive to successfully deliver comprehensive safety knowledge in a dynamic and engaged global team atmosphere. The Data Management department consists of more than 20 Safety Data Associates working globally with responsibility for handling adverse event reports and related activities for Lundbeck’s marketed as well as products under development with a tireless focus on patient safety.
We are now looking for a Specialist with at least 7 years’ experience working within PV with advanced knowledge of clinical development activities to be a go-to-person on the team, someone who is a driving force in devising and optimizing cross-functional processes and who is passionate about quality and patient safety.
Your job and key responsibilities
You will be responsible for helping to ensure consistency within Data Management in regard to processes and methodology and act as a key link between Data Management and other areas in the organization, e.g. clinical development. You will strive to ensure that adverse event reports and related activities are handled in compliance with global regulatory requirements and be a key support in quality oversight measures. You will provide guidance to the Data Management team in addressing operational issues related to clinical safety and core pharmacovigilance and support Lundbeck’s overall Safety Vision to be premier experts in global patient-centric PV. You will be a subject matter expert for the team as well as other stakeholders within GPS and Lundbeck and support projects and activities.
Qualifications
Our ideal candidate has the following personal and professional qualifications:
- 7+ years working PV experience in Data Management or similar area with focus on clinical trial activities
- background in natural sciences, e.g. pharmacist, veterinarian, biologist or specialized study nurse
- Solid understanding of global PV regulations and guidelines
- Working knowledge of case handling processes and reporting requirements in safety systems, such as eCRF and ARISg or similar
- Knowledge of coding principles, eg MedDRA and WHO DD
- Experience working with various stakeholders, eg. clinical CROs, clinical sites, study teams, regulators and business partners
- Understanding of principles around updating and maintaining steering documents, eg. Standard Operating Procedures
- Experienced in supporting in audits and inspections including CAPA plans
- Innovative mindset and ability to drive cross-functional initiatives
- Experienced in mentoring and guiding teams
- Adaptable and positive mindset
- Proficient in both written and spoken English
Further information
For further information, please contact Klara Box at kbox@lundbeck.com or +45 30 83 24 23. Your application and CV should not be sent via email.
We also recommend that you have a look at our website.
Your application
Please click on the link below to apply for the job. Applications must be received in English add no later than 11/Apr/2022
Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
Billions of people worldwide live with brain diseases – complex conditions often invisible to others that nonetheless take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Every day, we strive for improved treatment and a better life for people living with brain disease.
We have approximately 5,600 employees in more than 50 countries, and our products are available in more than 100 countries. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17.7 billion in 2020 (EUR 2.4 billion; USD 2.7 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Instagram (h_lundbeck), Twitter at @Lundbeck and via LinkedIn.
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