Job opportunities

Senior Specialist, Safety Physician


Region Hovedstaden




Research and Development

Application deadline

23 March 2018


Are you passionate about pharmacovigilance and psychiatry? Do you want to be part of a committed medical safety team engaged with the clinical development and life-cycle management of psychiatric medicine? Do you have strong background in pharmacovigilance and as a clinician, preferable in psychiatry? Do you possess the leadership skills to lead a safety team and cross-functional safety committees? If so, you may be our new Senior Safety Physician in Medical Safety Psychiatry.
As a function in R&D, within Medical & Regulatory Sciences, 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 newly formed Medical Safety department consists of 23 safety scientists and physicians, supporting medical safety and surveillance activities for products within psychiatry and neurology.  The Psychiatry team consists of 16 safety scientists and physicians, supporting products within psychiatry including development projects in clinical phase I to III as well as a large portfolio of post-marketed products for Schizophrenia, Bipolar Disorder and Depression.
The position is based at our headquarters in Copenhagen. 

Your job and key responsibilities
Reporting to the Director of Medical Safety - Psychiatry, your responsibilities will be to lead safety teams in the Medical Safety - Psychiatry Department.  You will be responsible for all aspects of clinical safety & surveillance related to allocated psychiatry projects/products. Key responsibilities will include:

  • Authorship, medical review and approval of individual case reports, PSUR, /DSURs, RMPs and regulatory response documents
  • Review and input to the safety components of the target profile, clinical development plan, clinical study protocols, IBs, study reports and regulatory documents.
  • Ensuring medical monitoring and safety review of on-going clinical studies and where necessary take leadership for data monitoring committee’s
  • Detection, analysis and management of potential safety signals arising from both marketed and pipeline products

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

We offer
We offer an excellent opportunity to take on a senior safety physician lead role within pharmacovigilance and contribute to the clinical development of new compounds and life-cycle management of existing products for the treatment of psychiatric diseases.

Our preferred candidate has the following personal and professional qualifications:

  • must be a medical doctor (preferably a psychiatrist but other clinical backgrounds will also be considered)
  • at least 5 years of pharmaceutical Drug Development and/or Pharmacovigilance experience in both pre- and post-marketing settings
  • strong leadership skills
  • has experience with regulatory requirements and EMA/ FDA guidelines
  • has experience in writing risk management plans
  • has experience in writing the safety parts of clinical study protocols, clinical overviews, clinical trial applications (CTA) and DSURs.
  • has experience in life-cycle management of post-marketing products including PSURs, renewals, ACO, line extensions, signal management, literature surveillance, post-authorisation safety studies
  • is fluent in written and spoken English
  • strong communication and presentation skills
  • has strong problem solving and decision making skills
  • proactive, responsible and well‑organised

Further information
For further information please contact Director of Medical Safety - Psychiatry Camilla Hammerum ( We also recommend that you visit our website

Your application
Please click on the link below to apply for the job. Applications must be received no later than
23rd March 2018.

Apply for the job here

Please apply for this job from a desktop/laptop computer.

Lundbeck is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease.

An estimated 700 million people worldwide are living with psychiatric and neurological disorders 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 psychiatric and neurological disorders – we call this Progress in Mind.


Our approximately 5,300 employees in 55 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have research centres in China and Denmark and production facilities in China, Denmark, France and Italy. Lundbeck generated revenue of DKK 14.6 billion in 2015 (EUR 2 billion; USD 2.2 billion).

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


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Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with psychiatric and neurological disorders.

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