Pharmacovigilance Scientist (Associate Director)
About the position The Pharmacovigilance (PV) Scientist role at Astellas Pharma Inc. is designed to support the Product Responsible Person (PRP) with primary responsibility for signal detection and case series data analysis. This position is based in Ontario, Canada, with the possibility of remote work from certain states in accordance with Astellas' Responsible Flexibility Guidelines. The PV Scientist will be a key member of the PV Product Responsible team, assisting in the medical-scientific monitoring and assessment of the safety profile of Astellas products. The role involves coordinating with various teams, preparing meeting materials, and supporting the PRP in driving projects forward while applying knowledge of therapeutic areas and regulatory science. Responsibilities • Assist the PRP in coordinating medical-scientific monitoring and assessment of the safety profile of Astellas products. • Prepare meeting materials/presentations for cross-functional meetings. • Attend meetings with the PRP as requested. • Support the PRP in driving projects forward within a global matrix. • Develop and update safety surveillance development strategies. • Perform safety signal detection and evaluation activities. • Support PRP in audits/inspections and CAPA commitments. • Provide guidance to Medical Writing vendor staff. • Support risk management activities and preparation of Risk Management Plans. • Draft revisions of RSI section and expected events list for the IB. • Prepare AOSE reports for IND SUSAR submission to the FDA. • Ensure accuracy, quality, and timeliness of all assigned responsibilities. • Assist with data requests and document preparation. • Support the Project Coordinator with scheduling and tracking deliverables. Requirements • Bachelor's degree with a related health science background or clinical pharmacy experience preferred. • At least two years of PV experience or associated field experience preferred. • Understanding of ICH/FDA regulations and guidelines affecting drug safety issues. • General understanding of safety signaling activities. • Competence in safety surveillance analysis and presentation. • Proficient with technology (Windows, Word, Excel, Outlook, PowerPoint). • Proficiency in MS Teams and SharePoint desired. • Proficiency in English language, both oral and written. Benefits • Medical, Dental and Vision Insurance • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks • 401(k) match and annual company contribution • Company paid life insurance • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions • Long Term Incentive Plan for eligible positions • Referral bonus program Apply tot his job