• Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
• •Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
• Develop knowledge of capabilities and limitations of various data sources.
• •Assist in the evaluation of potential safety issues and quality risk assessment reports utilizing all processes and templates utilized by the company.
•Contribute to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues.
• Proactively disseminates information to safety team members, providing context/urgency as applicable.
• Communicates clearly to all cross-functional areas including scheduling meetings to provide clarity and resolution of issues.
• Demonstrates alignment with core values
• Together with safety physician manages leads the authoring for aggregate safety reports (e.g. PSUR, DSUR, Line listings) in close collaboration with the cross functional lead and operational functions
• Supports all SRMT preparation and documentation with guidance from mentor and safety physician
• Working with affiliate management and regulatory to develop and edit SMPs/ESRPs and independently bringing issues related to SMPs and ESRPs for discussion with impacted parties
• Contribute to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues.
• Provide management and training for new staff on department practices and therapeutic area knowledge.
• Identifies gaps in overall processes and initiates change as appropriate.
Education: Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required
...Posting Date 04/10/2025 1172-74 South Broad Street, Philadelphia, Pennsylvania, 19146, United States of America DaVita is hosting a virtual hiring event on 3/8 for Registered Nurse's (RNs) who are looking to give life in an outpatient setting! Openings available...
...To Protect Every Child & Serve All Working People American Income Life has been... ...working virtually from the comfort of their homes. The ideal candidate is results-driven... ...the support of the entire team Sales experience is an asset but not required Daily...
...community that values: Flexible scheduling across home-based, teletherapy, and hybrid service delivery models Individual autonomy in... ...practices Comprehensive clinical resources and supportive SLP community Professional development opportunities in...
...clients and customers. Responsible for renewals on existing block of business. Upsell/cross-sell additional product lines within Cigna Global and other matrix partners. Educate clients about Cigna Global updates/changes related to compliance or processes....
...work to thrive. Account Management sets the tone, pace and ways of working. Account people must weigh and balance client needs with agency ambitions to determine the vision, and then make sure everyone is clear on that vision and how to get there. Account Managers...