Pharmacovigilance Scientist (Associate Director)

About the position

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