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 is looking for an MD with significant experience in clinical safety and pharmacovigilance for the PV Director position, reporting to the Head of Patient Safety.
You will take full responsibility for the safety strategy and surveillance of a clinical project.
The successful candidate will have the below qualifications:
- Development and execution of the safety surveillance strategy and activities for the projects assigned, including NDA/MAA filing, other regulatory interactions
- Provide drug safety expertise and support to project teams, including preparation of all relevant documents for regulatory submissions
- Execution of signal detection activities, to support the evaluation and decisions of Zealand Safety Committee
- Preparation of periodic safety reports
- Preparation of 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, NDA/MAA filings, 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
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 employee share 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 www.zealandpharma.com
Please apply in English no later than May 9, 2021.
For further information, please contact Head of Patient Safety, Liliana Hansen at +45 5060 3818.
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.