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Safety Lead

 
Requistion ID:  439
Location: 

Copenhagen, N/A, DK

Date:  01-Jul-2019
 

Safety Lead, Medical Safety Neurology, Pharmacovigilance Medical Safety

 

Do you want to be part of an innovative science team aiming to develop therapies for the treatment of neurological diseases? Do you have a strong background in pharmacovigilance and clinical development of therapeutic antibodies, or advanced therapy medicine products? Do you possess analytical skills and ability to perform risk assessment of medicinal products? If so, you may be our new Safety Team Lead in Medical Safety Neurology. The position is in our Pharmacovigilance department located at our headquarters in Copenhagen.

 

As a function within Medical Affairs, Pharmacovigilance is responsible for the safety surveillance and benefit-risk assessment of all Lundbeck’s pharmaceutical products, including pipeline and established products. We presently consist of more than 60 dedicated colleagues who strive to successfully deliver comprehensive safety knowledge in a dynamic and engaged team atmosphere. The Medical Safety department consists of more than 20 safety scientists and physicians, supporting medical safety and surveillance activities for products within psychiatry and neurology. 

 

 

Your job and key responsibilities

You are an experienced safety physician who can add valuable knowledge to our immunological science teams in neuroscience. The Safety Lead is accountable for all aspects of safety related to a product or a group of products in the clinical phases I, II and III. Key responsibilities include input to the safety components of the target profile, clinical development plan, clinical study protocols, study reports, DSURs and Development RMPs.

 

You will work in in a cross-functional organization with your colleagues from pharmacovigilance, project leaders, clinicians, regulatory affairs, medical affairs, pre-clinical toxicology, biometrics, clinical pharmacology, CMC, and external agents in an international environment with great opportunities to develop your personal and professional skills.

 

We offer

We offer an excellent opportunity to take a key safety lead role and thereby contribute to the development of new innovative treatments of neurological diseases.

 

Qualifications

Our preferred candidate has the following personal and professional qualifications:

  • is preferable a medical doctor, holds a master or PhD in immunology or has another relevant background in natural sciences
  • has preferable experience with drug development in neurology and/or immunology
  • has solid experience in pharmacovigilance
  • has experience with regulatory requirements and FDA guidelines for first-in-man studies with therapeutic antibodies
  • has experience with assays for immunogenicity and risk management of immune-related adverse events
  • has experience in writing clinical study protocols, safety overviews/safety sections of IB, clinical trial applications, DSURs and RMPs
  • has strong problem solving and decision-making skills
  • is a team player with a collaborative mindset
  • has a positive attitude to challanges
  • can work against tight deadlines, has a good sense of urgency and cope well under pressure
  • is keen on working in an international, multi-cultural corporate environment
  • speaks and writes English fluently
  • thrives in a feedback culture
     

Further information

 

For further information please contact Head of Medical Safety Neurology Claudia Pierleoni (cpn@lundbeck.com). We also recommend that you visit our website www.lundbeck.com

 

Your application

Please click on the link below to apply for the job. Applications must be received no later than July 28th, 2019.

 

 

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.


An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.
Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.