Valerie Opher, RN MAS DM

The contract concluded and position was eliminated during reorganization.

• Collaborated with clinical teams to analyze safety data and trends, enhancing decision-making processes.
• Monitored adverse event reports for adherence to regulatory guidelines and company policies.
• Engaged cross-functional teams to address safety issues and propose effective resolutions.
• Developed standard operating procedures to improve efficiency in adverse event reporting.
• Tracked quality metrics in pharmacovigilance activities, ensuring compliance with regulations and enhancing operational excellence.
• Established partnerships with external vendors to improve pharmacovigilance service delivery.
• Provided guidance to colleagues to maintain a supportive and collaborative work environment.
• Identified customer needs promptly, ensuring high satisfaction through effective problem resolution.

• Maintained strict confidentiality in clinical trial research, including DSMB and FDA correspondence.
• Managed daily DMC/DSMB mailbox operations, facilitating timely communication and resolution of inquiries.
• Scheduled and moderated 2-5 monthly DSMB Board meetings for NIH and NIAID.
• Drafted monthly preliminary and final recommendations, meeting summaries, and closed session notes to support informed decision-making.
• Conducted thorough reviews of safety sections in protocols, ensuring adherence to regulatory standards and safeguarding participant welfare.
• Reviewed 2-50 study data reports per review while moderating closed sessions.
• Led support team in executing DSMB-related tasks with consistency.
• Participated in bi-weekly meetings with support team and Sponsor representatives to resolve DSMB issues.

• Developed and implemented safety monitoring plans, analyzing data for signal detection.
• Processed up to ten safety events monthly while conducting ongoing medical reviews to support regulatory compliance and patient safety.
• Monitored clinical safety and pharmacovigilance mailbox, executing daily operational safety processes to ensure timely resolution of safety inquiries.
• Tracked periodic safety update reports using database management software, improving accuracy in data reporting for regulatory submissions.
• Conducted regular reviews of study-related documents to ensure compliance with standards.
• Collaborated with cross-functional teams to facilitate timely exchange of critical drug safety information.
• Promoted compliance with NIH and NIAID regulations among Principal Investigators within two weeks.
• Served as a resource on complex case evaluations, fostering a culture of learning.

• Provided comprehensive care for five family members with chronic illnesses over seven years, ensuring their daily needs were met.
• Managed healthcare processes, coordinating transportation, medication administration, and meal preparation to enhance quality of life.
• Advocated for patients to achieve social, health, medical, and financial goals, facilitating access to necessary resources and support.
• Contemplated grief after losing family members.
• Engaged in lifelong learning through philosophy, poetry, chess strategies, and professional development courses.

• Instructed graduate-level business courses, including Quantitative Strategies, Business Ethics, and Strategic Management.
• Facilitated inaugural worldwide leadership certificate course for C-suite professionals from seven countries.
• Fostered participatory learning environment by addressing diverse student needs and enhancing inclusivity to improve student engagement.
• Enhanced faculty collaboration through active participation in departmental meetings and initiatives, strengthening professional relationships.

• Collaborated with matrix teams and FDA to ensure compliance, accelerating approval timelines for Crestor by streamlining processes.
• Cultivated relationships with key stakeholders to secure funding for four cardiovascular research initiatives, enhancing research capacity.
• Established quality control measures for US and global clinical trials, defining data milestone targets.
• Optimized resource allocation within academic institutions and KOLs, achieving annual operational cost reductions of three to six percent.
• Enhanced research outcome precision by over five percent quarterly through improved methodologies.
• Managed ongoing safety monitoring plans on matrix teams to evaluate safety data.
• Tracked periodic safety update reports using database management software, improving efficiency and accuracy.
• Reviewed and edited study documents regularly, ensuring adherence to accuracy and compliance standards.

• Established team priorities and monitored performance to advance diversity initiatives across the US.
• Cultivated relationships with internal and external customers to enhance collaboration and drive project success.
• Supported and guided six team members, fostering a positive team environment and enhancing collaboration.
• Managed five projects through effective organizational and time management skills.
• Ensured timely completion of all project tasks by efficiently managing budget and deadlines.
• Defined clear project targets and communicated expectations consistently to team members.
• Created five to ten focused working groups to tackle cardiovascular disease issues.
• Contributed to a 12-30% increase in recruitment of PIs and 10-15% for persons of color.

• Acted as cardiovascular diseases SME for internal teams and external customers in Pennsylvania, West Virginia, and Ohio.
• Engaged in scientific exchanges with community KOLs and academic researchers, fostering relationships and knowledge sharing on a regular basis.
• Conducted 3 to 8 educational sessions weekly for KOLs, enhancing participant skill sets through feedback.
• Facilitated communication of scientific data during internal and external discussions, enhancing understanding and alignment on key topics.
• Led interdisciplinary research projects, integrating diverse perspectives on complex scientific questions.
• Spearheaded design and execution of 2 impactful research projects at leading academic institutions.
• Fostered collaborations with federal partners (FDA, NIH), broadening scientific inquiry scope.
• Transformed intricate scientific content into accessible information, increasing audience engagement and comprehension across regions.