Be the new
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a fast-growing, fully integrated Copenhagen-based biotechnology company with a highly attractive pipeline. With one product on the market, one candidate in registration and six candidates in the clinical pipeline, Zealand is a unique success story in Danish biotech. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs. In addition to the Søborg Headquarters, Zealand is also located in the United States in Boston (MA), Marlborough (MA), and New York (NY).
Zealand Pharma A/S (Zealand) is looking for a MD with significant experience in clinical safety and pharmacovigilance for the Pharmacovigilance Director position, reporting to the Head of Patient Safety.
You will take full responsibility for the safety strategy and surveillance of a clinical project.
Responsibilities includes helping us to:
The successful candidate will have most or all of the below qualifications:
- Develop and execute the safety surveillance strategy and activities for the projects assigned
- Provide drug safety expertise and support to project teams, including preparation of all relevant documents for regulatory submissions
- Execute the signal detection activities, to support the evaluation and decisions of Zealand Safety Committee
- Prepare the periodic safety reports
- Prepare the Risk Management Plan (RMP) and/or Risk Evaluation and Minimization Strategies (REMS) documents
What we offer
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
- MD degree
- At least 7 years of in-depth, hands-on work experience with drug development in general and in particular with drug safety/pharmacovigilance processes applied in safety surveillance (safety analysis, signal detection and management, DSUR/PSUR, RMP/REMS, internal safety committees, communication with regulatory authorities)
- Solid understanding of the PV (EU and FDA) requirements
- Strong analytical skills
- Ability to communicate and interact maturely with internal and external stakeholders
- Strong ethical standards
- Quality mind-set
- Team-player mindset
Our work environment is characterized by strong cross functional team-work, room for individual performance and development, informality and respect, high work-ethics and engagement, and fun.
At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.
We offer a combined compensation package which includes a base salary, pension, bonus, and an attractive warrant program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities. To find out more about working at Zealand, visit our careers site and view our company video at:
Please apply no later than September 30, 2020.
For further information, please contact Liliana Cristina hansen
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals.Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.