Be the new
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) aims to become a fully integrated biotechnology company leading in delivery of specialty medicines. 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.
Are you also passionate about making a real difference for patients with rare diseases? Are you thinking to make a career change and be part of a very dynamic, ambitious, professional, yet lean and agile team where you can have influence? Then you may be our new colleague in Regulatory, Pharmacovigilance and Medical Writing.
Zealand Pharma A/S (Zealand) is looking for an MD with significant experience in clinical safety and pharmacovigilance for the PV Manager position, reporting to the Head of Pharmacovigilance.
The key responsibilities will be:
- Ongoing safety surveillance
- Signal detection and management
- Aggregated safety reporting
The Job Requirements
- Development and execution of the safety surveillance strategy and activities for the projects assigned
- Execution of signal detection activities, to support the evaluation and decisions of Zealand Safety Committee
- Preparation of high quality periodic safety reports (DSUR, periodic SUSAR reports)
- Preparation of Risk Management Plan (RMP) and/or Risk Evaluation and Minimization Strategies (REMS) documents
- 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
The Candidate Profile:
The successful candidate will have:
What we offer:
- 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
Zealand’s employees are one of the company’s most important assets, and we strive to attract, develop and retain the best talents, and to be a company where employees thrive.
At Zealand, we understand the value of a diverse workforce, and as an employee you will be part of an innovative cross-disciplinary and cross-cultural working environment.
We offer a combined salary package including pension scheme and health insurance, as well as the option of joining the company lunch program, and use of massage, fitness and social facilities.
To find out more about working at Zealand, visit our careers site and view our company video at:
Please send your resume/CV and cover letter no later than January 2, 2020.
For further information please contact Senior Director & Head of Pharmacovigilance Liliana Hansen at
+45 50 60 38 18.
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. Zealand’s portfolio also includes two clinical license collaborations 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.