Sr. Manager/Associate Director, Pharmacovigilance

Hansa Biopharma•New York, NY

6d•Hybrid

About The Position

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.

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

Nice To Haves

Transplant and/or rare disease and nephrology experience preferred
US launch experience preferred

Responsibilities

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