Safety Manager
India Bangalore
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
Reporting to the Director of Safety Monitoring, the Therapeutic Area Safety Manager will manage all activities of all Safety Monitors assigned within the Therapeutic Area, to include utilization and training requirements. The incumbent will support in the development of an assigned Therapeutic Area Safety Group, mentoring junior staff as direct reports, and will be responsible for coordinating the safety aspects of projects in conjunction with the Medical Monitor and project team.
Supervises and oversees a team of Safety Monitors within Therapeutic Area (TA) to implement Clinical Safety and Pharmacovigilance Group (CSPG) activities and reach objectives
- Provides direct supervision of TA Safety Monitors, including resource management, training, quality of service to Projects, and supervising the career paths of staff
- Consults with Project Manager (PM) and Therapeutic and Research Unit (TRU) Leads regarding upcoming and ongoing project Safety Monitor requirements
- Consults with the Director of Safety Monitoring to align personnel qualifications and utilization targets with TRU PM requirements, ensuring TA project resources are utilized appropriately per contract
- Under the direction of the Director of Safety Monitoring, provides budgetary input in proposals or protocol design for designated TA
- Provides input in the creation and maintenance of SOPs and Work Instructions that accurately reflect the standards of activities falling under the responsibilities of TA Safety Monitors
Coordinates safety monitoring activities with Project Medical Monitor
- Reviews safety events
- Provides first line evaluation of serious adverse events
- Communicates with site staff regarding reported AEs or SAEs to gather additional information
- Prepares a summary narrative for each reported SAE suitable for inclusion in DSMB reports, regulatory submissions, and final study reports
- Maintains ongoing database of SAEs and reconciles SAEs in the database as needed
- Reviews adverse events for the study on a regular basis
Communicates with sponsor, investigator site staff, pharmaceutical, and other study partners
- Responds to site, sponsor, and pharmaceutical partner requests for information regarding safety in clinical trials
- Participates in Data Safety Monitoring Board (DSMB) or other safety review committee (SRC) meetings as necessary
- Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual report and periodic safety reports
Coordinates with project staff
- Participates in project team meetings
- Participates in the planning, preparation, and development of all safety-related sections of protocols, study specific Manual of Operations (MOP), project SOPs, and ancillary documents to ensure project compliance with corporate SOPs
- Contributes to the development and implementation of the safety Case Report Forms (CSF) and Safety Monitoring Plans (SMP)
- Maintains documentation required by corporate and project SOPs
- Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/ Variance table development, participation in both internal and external audits, as well as professional development activities
Performs MedDRA and WHO Drug coding, as applicableParticipates in other corporate activities including annual SOP reviews, development and teaching of Emmes internal classes, participation in corporate safety meetings/activities, and other corporate pharmacovigilance activitiesReviews informed consent document and provides input, as applicableOther duties as assigned
- RN degree, PA degree, or Bachelor's degree in a scientific discipline with equivalent clinical experience
- Demonstrated experience with clinical trial data collection and total of 8 years in clinical research with 3-5 years experience in safety monitoring/pharmacovigilance, including demonstrated experience with mentoring staff
- Demonstrated use of medical terminology and ability to extract information to create a case history
- Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically and medically sound and understandable way
- Excellent oral and written communication skills
- Ability to work as a team member and function on a cross-functional team
- Working knowledge of MedDRA and WHO Drug coding strongly preferred
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