Pharmacovigilance Manager
Would you like to be part of a growing biopharma company?
Hansa Biopharma is a fast-growing, commercial-stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life altering treatments for patients with rare immunological conditions.
Our broad therapeutic pipeline based on the company’s proprietary IgG-cleaving enzyme technology platform has potential to address serious unmet medical needs in autoimmune diseases, gene therapy, and transplantation.
By empowering our people and working in an agile way we move our projects forward with high speed, efficiency and scientific excellence. We strive to attract leading talent from around the world, broaden our network of partners and establish a presence in key markets around the world. There are many opportunities for highly qualified, motivated, and passionate team players to join us on our exciting journey.
Hansa Biopharma was founded in 2007, with the corporate headquarters in Lund, Sweden and has operations in other European countries and in the US. The Company has been listed on the Nasdaq First North Growth Market Stockholm from 2007 to 2015 and on the Nasdaq Stockholm since 2015.
Position: Pharmacovigilance Manager
As a Pharmacovigilance Manager you will be involved in the operational and surveillance pharmacovigilance activities including but not limited to collection of adverse events from various sources, assessment and reporting of individual case safety reports (ICSRs), signal detection and compilation of aggregated safety reports.
In this position, you are reporting to the Head of Pharmacovigilance and QPPV at Hansa Biopharma.
You will be part of development projects together with colleagues representing all disciplines within the company. You will often liaise with external parties - mainly consultants and collaboration partners.
Principal Responsibilities
- Contribute to the maintenance of the pharmacovigilance system at Hansa Biopharma, including writing/reviewing of the PSMF and processes/SOPs
- Review and approval of adverse events from clinical trials and post-marketing
- Review of and give input to safety sections in clinical trial protocols and reports
- Write and/or review aggregated safety reports such as DSURs and PBRERs/PSURs
- Write, review and/or update risk management plans (RMPs)
- Be involved in and contribute to safety overview activities, such as signal detection
- Give input on safety to regulatory documents
- Collaborate with our pharmacovigilance vendor
- Participation in internal & external fora (e.g. external Data Monitoring Committees, internal Safety Committees etc)
- Provide guidance, oversight, and pharmacovigilance training to relevant stakeholders (e.g. Hansa Biopharma employees, vendors, investigators etc)
Professional Qualifications
In order to succeed in this position, we believe that you should possess:
- University degree in Life Science, pharmacy, or similar
- At least two years of experience in pharmacovigilance including case processing and regulatory submissions, preferably covering clinical development and post-marketing
- Fluency in written and spoken English
The following experience is desirable:
- Experience in clinical and post-marketing case processing, including MedDRA and WHODrug coding, triage, medical review and narrative writing
- Ability to interpret health and medical records such as adverse event forms, discharge summaries, etc
- Good knowledge of global pharmacovigilance regulatory requirements, MedDRA and WHODrug coding dictionaries
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:
- You work independently and make decisions and execute them as needed
- You are excellent in detailed-oriented tasks, and in analytic and strategic thinking
- You are highly ambitious, and you plan and handle your work proactively and successfully
- You are a team player and value collaboration among colleagues
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:
- Self-motivated
- Doer
- 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:
- Brave
- Empathetic
- Lead-by-example
All these behaviours will be assessed at various stages of the recruitment process.
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. We offer a hybrid way of working; the position requires close collaboration and networking; we would therefore love to be able to meet you in person at least 2 - 3 days per week.
The process
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.
The last day for applications is 26 May 2024, but we will review applications as they are received and may ultimately close the process earlier.
For questions regarding the position and process, please contact the recruiting manager: Mette Kallesøe at mette.kallesoe@hansabiopharma.com.
We look forward to receiving your application – join us and make significant contributions to Hansa Biopharma´s research!
- Department
- Pharmacovigilance
- Locations
- Lund
Lund
Pharmacovigilance Manager
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