Position summary : Sr. Manager/Associate Director, 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

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.

Department R&D - 98500 - Pharmacovigilance Locations New York Remote status Hybrid