Feba Fredi, PharmD

• Contributed to the Recruitment and Development Committee at Northeastern University Recreation, enhancing student staff recruitment and training processes. • Designed and implemented onboarding programs and mentorship initiatives to empower student leaders. • Advocated for inclusive hiring practices, aligning with the university's commitment to diversity and fairness. • Fostered a supportive environment that promotes professional growth among student staff.

• Ensured a safe and welcoming environment by enforcing policies and adhering to established protocols. • Promoted safety awareness and proper techniques, demonstrating strong attention to detail. • Fostered effective communication with participants and staff, enhancing collaboration and engagement. • Adapted to dynamic situations, showcasing problem-solving skills and a commitment to continuous improvement.

• Implemented ICH GCP (E6/R2) guidelines across trial operations, ensuring continuous compliance with quality standards. • Led a randomized clinical trial comparing two Ipratropium Bromide HFA formulations in COPD patients, ensured compliance, and facilitated sponsor-investigator coordination. • Maintained inspection-ready trial documentation and facilitated sponsor/regulatory audits through accurate master file management. • Streamlined the return of investigational products and resolved outstanding data queries and discrepancies, ensuring timely database lock and compliance with study closeout protocols. • Coordinated investigational product returns, supported compliance reviews during monitoring visits, and ensured proper study closeout. • Enhanced regulatory documentation accuracy by developing standardized tracking logs, improving reporting consistency for IP return and AE management.

• Collaborated with multidisciplinary healthcare teams to ensure compliance with regulatory guidelines by providing evidence-based drug and poison information, supporting the safe and effective use of therapeutics. • Documented and reported ADRs related to drugs and medical device to the Pharmacovigilance Programme of India (PvPI), supporting post- marketing surveillance and GVP compliance. • Led safety and quality improvement initiatives, including incident reporting and dose optimization, contributing to continuous quality improvement. • Enhanced patient adherence through targeted counseling, supporting regulatory standards for safe medication use.