Sr. Manager/Associate Director, US Pharmacovigilance

About us 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 acute or complex immune disorders. 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 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 summary : Sr. Manager/Associate Director, US Pharmacovigilance Responsible for processing of safety data related to Hansa authorised product(s) and clinical development programmes in a global capacity. This is a hybrid position in the NYC office once established. The individual will report to the Senior Director, Head of Pharmacovigilance QPPV. Key tasks and responsibilities This job description outlines key responsibilities but does not include all potential tasks or duties.

• Contribute to the development and maintenance of the pharmacovigilance system for Hansa Biopharma AB, including the quality system for the performance of pharmacovigilance activities
• Have full knowledge about current regulation and guidelines within pharmacovigilance, however focused on FDA legislation
• Have an overview of the product(s)’s safety profile where Hansa Biopharma AB is the marketing authorisation holder (MAH)
• Review and approve SAE and ICSR reports
• Review and give input to safety sections in protocols and reports for trials, such as clinical trials, non-interventional trials, post-authorisation safety studies (PASS)
• Write and/or review aggregated safety reports such as the US PADER, DSUR, PSUR/PBRER, as needed
• Give input on safety sections/documents and analysis, e.g. for MAA/BLA, as needed
• Write and/or review the RMP(s) (EU) and REMS(s) (US), as needed
• Review and give input to protocols and reports for trials, such as clinical trials, non-interventional trials, post-authorisation safety studies (PASS)
• Contribute to and participate in the monthly meetings with the pharmacovigilance vendor
• Contribute to and participate in the QPPV Oversight Meetings
• Participate in Safety Committee Meetings
• Participate in pharmacovigilance audits and inspections
• Contribute to the writing/update of relevant SOPs for pharmacovigilance
• Support in the pharmacovigilance training for the staff in the US, as needed
• Contribute to the update/maintenance of the Pharmacovigilance System Master File (PSMF)
• Collaborate with and oversee pharmacovigilance vendors and other vendors impacting the pharmacovigilance system
• Provide guidance and pharmacovigilance training to relevant external stakeholders
• Support the Regulatory Affairs department, including providing input on response to authorities and regulatory actions regarding any safety issue
• Work in accordance with Hansa Biopharma’s SOPs and give regulatory/pharmacovigilance comments on other applicable SOPs, as needed
• Some domestic / international travel expected

Education and experience requirements

• Bachelors degree required; Masters degree preferred in the medical field
• 6+ years of experience in pharmacovigilance
• Prior experience working in a fast paced, growing pharmaceutical or biotech environment preferred
• Experience effectively managing external agency partners and collaborating with cross-functional teams and internal/external stakeholders to effectively implement strategies and programs
• Agility, proven ability to influence without authority and cross-functional collaboration
• Ability to work under pressure in a fast-paced environment and prioritize work to achieve positive results
• Ownership mentality, willingness to roll up sleeves and flexibility to jump in where the business needs dictate
• Understanding of the legal and regulatory environment in pharmaceuticals
• Strong communication and organization skills
• Ability to work independently and with an international team
• Transplant and/or rare disease and nephrology experience preferred
• US launch experience preferred

Our culture and values Working at Hansa is more than a job for us, and our culture is characterised by pride — pride in what we do, in our company, and in what we have achieved and will accomplish for patients around the world. Our culture is built on our core values: Accountability, Courage, Integrity, and Pioneering. These values guide how we work, collaborate, and make decisions every day. 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. Reasons to join the Hansa Team A position in a company that envisions life changing outcomes for patients with acute or serious immune mediated conditions. 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. Friendly, motivated and skilled colleagues with whom you can both laugh and work. Hansa is an equal opportunity employer that values diversity. We provide equal opportunities to all employees and applicants for employment and prohibit discrimination or harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, marital status or any other characteristic protected by federal, state or local laws. Estimated salary range for this role is $175,000 - $215,000 annually. The actual base salary offered may depend on a variety of factors, including the qualifications, skills and experience of the individual applicant, level of education attained, certifications or other professional licenses held, and the geographic location of the individual. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives, as well as participation in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, company holidays and well-being benefits. Location On-site/Hybrid position in NYC Office The process All applicants should apply on Hansa Biopharma’s website to be considered for employment. We do not accept unsolicited candidate introductions or referrals from third party recruiters and staffing agencies, and we are not responsible for any fees associated with unsolicited referrals. Attach your CV in English only. Unfortunately, we are unable to review applications made in other languages. The process is ongoing and we will review applications as they are received. 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.