Head of Pharmacovigilance, QPPV
Would you like to be part of a growing biopharma company?
Hansa Biopharma is a fast-growing biopharmaceutical company that is developing immunomodulatory treatments for enabling transplantations, rare immunoglobulin G (IgG)-mediated autoimmune conditions, gene therapy and cancer. The Company’s lead product candidate, imlifidase, has been granted conditional approval in the European Union to desensitise highly sensitised adult kidney transplant patients with a positive crossmatch against an available deceased donor. Commercial launch of imlifidase in select European countries is ongoing.
Hansa’s research and development program is also advancing the Company’s enzyme technology to develop the next generation of IgG-cleaving enzymes with potentially lower immunogenicity, rendering them suitable for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden and has operations in other European countries and the US.
Position: Head of Pharmacovigilance, QPPV
As a Head of Pharmacovigilance, QPPV, together with the deputy QPPV, you will be responsible for the pharmacovigilance system at Hansa Biopharma. In this position, you are reporting to the Vice President Regulatory Affairs at Hansa Biopharma.
You will be part of several projects together with colleagues representing all disciplines within the company. You will often have contacts with external parts - mainly consultants and collaboration partners.
- Act as the QPPV for Hansa Biopharma
- Develop and maintain the pharmacovigilance system at Hansa Biopharma, including writing/reviewing of the PSMF and processes/SOPs
- Ensure overview of Hansa product’s safety profile
- Overview of the handling of SAE in clinical trials and spontaneous reports from the market
- Review and approval of processed cases from clinical trials and post-marketing
- Review and give input on safety sections in clinical trial protocols, clinical trial reports and other trial documents
- Review and give input to Data Monitoring Committee documents
- Write and/or review safety reports such as DSUR and PBRER/PSUR
- Write, review and/or update risk management plans (RMP)
- Be involved and contribute to safety overview activities, such as signal detection
- Give input on safety to regulatory documents
- Oversee pharmacovigilance vendors
- Responsible for the pharmacovigilance training of staff
- Give pharmacovigilance input to other departments, such as Clinical Operations, Commercial, Medical Affairs
In order to succeed in this position, we believe that you should possess:
- University degree in Life Science, pharmacy, or similar
- At least five years of working experience in pharmacovigilance
- Good knowledge of the pharmacovigilance quality system
- Fluency in written and oral English
The following experience is desirable:
- Experience in pharmacovigilance work, both in clinical studies and post-marketing
- Experience in pharmacovigilance in Europe and the US, other regions is a merit
Our culture and behaviours
Working at Hansa is more than a job for us and our culture is characterised by pride. Pride in what we do, in the company and in what we have, and will, accomplish for patients around the world. Our culture is supported and enhanced by our behaviours, and above and beyond professional qualifications and experience, we look for the following behaviours in all our future colleagues:
- Team player
Our people mean everything to us, and so our leaders, in addition to the above, must also be able to evidence the behaviours below:
All these behaviours will be assessed at various stages of the recruitment process.
You as a person
As colleagues, we genuinely care about each other. We are friends, empowering one another and appreciating everyone’s unique traits and contributions, and we believe in working together as a team. To foster the best possible organisational match in this role, we hope that you recognise yourself as having the following characteristics:
- Takes initiative and responsibility for actions and projects, acts with confidence
- Demonstrates an interest in and understanding of others; listens, consults others, and communicates proactively
- Develops job knowledge and expertise through continual professional development
- Works strategically to realise organisational goals; sets and develops strategies
- Works productively in high-pressure environment
Hansa is for everyone
At Hansa we aspire to be a truly great place to work. We know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the countries and communities in which we operate and ultimately the patients we exist to serve. Our recruitment policy is simple - hire the best person for the job.
What we offer
- A position in a company that envisions a world where patients with rare immunological diseases lead long and healthy lives.
- The chance to be part of an innovative R&D-driven organisation with a strong desire to make a difference for people.
- An opportunity to build a fully integrated biopharmaceutical company with global outreach.
- An open-minded and welcoming atmosphere. We care about our employees and are immensely proud to have been certified “A Great Place to Work” by Great Place to Work®, a global authority on workplace culture, employee experience and leadership behaviour.
- Friendly, motivated and skilled colleagues with whom you can both laugh and work.
Type of employment
This is a permanent and full-time (40 hours) position.
Hansa Biopharma is based in Lund, Sweden.
Please apply for the position through the following link. Applications should not be sent through any other platform.
Attach your CV and a cover letter in English only. Unfortunately we are unable to review applications made in other languages.
Our selection process is continuous and the advert may close before the recruitment process is completed if we have moved forward to the screening or interview phase, so we recommend to apply sooner than later.
For questions regarding the position and process, please contact the recruiting manager: Katja Gustafsson at email@example.com
We look forward to receiving your application – join us and make significant contributions to Hansa Biopharma´s research!
Please note: No external recruitment support is required. Only applications received directly will be considered.
- Regulatory Affairs
- Remote status
- Hybrid Remote
Head of Pharmacovigilance, QPPV
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