Be the new
Pharmacovigilance (Associate) Director or Senior Specialist
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a Copenhagen-based biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. 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. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence the U.S. as well.
In Patient Safety we expand, and are looking for a new colleague, experienced in clinical safety surveillance spanning early phases of clinical development through regulatory dossier preparations for NDA/MAA.
Patient Safety in Zealand Pharma is a lean, cohesive team of MDs and Pharmacists with a lot of experience. Our new colleague will have the opportunity to make very important contributions to Zealand clinical projects and to our team. All of these: in a unique environment, based on respect and collaboration.
The successful candidate will be a MD or Pharmacist (CandPharm)- with at least 5 years hands-on work experience with clinical safety and pharmacovigilance processes applied in safety surveillance (safety analyses, signal management, DSUR/PSUR, RMP/REMS, internal safety committees, labelling activities, communication with regulatory authorities).
Solid knowledge of the drug development value chain is of course expected.
Besides your education background and professional qualifications, we value individuals who:
- Representation of patient safety in cross-functional project teams, including regulatory interactions teams
- Development of the safety surveillance strategy for the project assigned
- Execution of signal detection activities, to support the evaluation and decisions by the internal Zealand Safety Committee
- Safety analyses and aggregated reporting to regulatory authorities
- Preparation of Risk Management Plan (RMP)/Risk Evaluation and Minimization Strategies (REMS)
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.
Zealand DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.
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.
Application should be made in English and no later than January 25, 2023.
For further information, please contact Liliana Hansen, Head of Patient Safety at +45 5060 3818 or at firstname.lastname@example.org
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen: 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.
- Have high ethical standards
- Have quality mind-set
- Are team players
- Have ability to communicate and interact with internal and external stakeholders