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
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