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Senior Specialist Pharmacovigilance

An opportunity to contribute to the clinical development of innovative therapies in certain rare diseases and to influence the development of the PV function in a fast growing biotech company

As Senior Specialist Pharmacovigilance at Zealand Pharma you will be part of the department based in Zealand Pharma’s HQ in Glostrup. In collaboration with the Pharmacovigilance Team, you will be responsible for all drug safety related activities for late stage development projects.

With direct report to Senior Director, Head of Pharmacovigilance.

Your main tasks are:

  • Development and execution of safety surveillance strategy for assigned clinical projects
  • Execution of signal detection activities, to support the evaluation and decisions of Zealand Safety Committee
  • Preparation of high quality aggregated periodic safety reports (DSUR, periodic SUSAR reports)
  • Preparation of Risk Management Plan (RMP) and/or Risk Evaluation and Minimization Strategies (REMS) documents
  • Preparation of the Company Core Safety Information (CCSI)
  • Support the design and execution of the assigned clinical programs from a clinical safety perspective
  • Provide drug safety expertise to project teams, including all relevant documents prepared for regulatory submissions for the assigned clinical programs
  • Collaboration with external experts and partners involved in the clinical projects assigned
  • Interaction with safety CROs


Qualifications required of the position:

Overall you have the ability to formulate and convey clear and consistent messages regarding the safety profile of the compounds under responsibility to regulatory agencies and key stakeholders. You have a minimum of 5 years experience of relevant safety execution, preferably in phase III. It will be an advantage if you have experience with development programs within rare diseases, diabetes, or gastrointestinal diseases. You have in-depth, hands on experiences working especially with the PV processes applied in safety surveillance, including internal safety committees, safety analysis, signal manageemnt, and communication with regulatory authorities. You also have experience working at a CRO or in collaborating with CROs.

You hold an academic degree preferably as MD or another relevant science degree such as M.Sc.Pharm, DVM, Human Biologist or similar. Additional degrees within Pharmaceutical Medicine or Pharmacovigilance will be an advantage.

You have excellent English communication skills, both written and oral, and you are an advanced user of MS Office, Access, and other relevant IT tool or system

You are a person who can motivate others, and you are an excellent team-player. You have experience working in a matrix organization and a documented track record of advancing projects. You are open to challenges, adaptable, and you thrive in a dynamic research environment. It is important that you are passionate about creating a sustainable footprint bringing new medicines and associated solutions forward to patients.

At Zealand Pharma you will be part of a stimulating and informal innovative working environment, where you will interact with both colleagues and partners to deliver on ambitious corporate goals.

Travelling: 10 – 20 days/year

Domicile: Glostrup, Denmark

For more details about the job or the company, please contact Partner Jørn Duhn, Unique Human Capital on M +45 21 75 19 25. All applications must be in English and will be treated confidentially.

 

Zealand Pharma offers an exciting, interdisciplinary, and challenging job in a workplace that encourages continuous learning at work and sharing of best practices. They have an inclusive corporate culture, where they believe in development of their employees. All employees at Zealand benefit from a combined remuneration package including pension scheme and health insurance as well as lunch plan, massage, fitness room, and social clubs.

Read more at www.zealandpharma.com

Unique Human Capital A/S
T +45 7020 6700
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cvr: 31502705
Stamholmen 157, 1. tv
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Marselis Tværvej 4
8000 Aarhus C
Unique Human Capital Poland Sp. z o.o.
T + 48 22 291 32 20
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ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland