[Hiring] Safety Manager @Emmes Group

Role Description

The TA Safety Manager will implement Pharmacovigilance and Medical Monitoring (PMM) activities in collaboration with other members of the PMM group. The incumbent will supervise and manage activities of Safety Monitors and administrative support employees working in PMM (if relevant) and supervise the services of Pharmacovigilance contractors (if relevant) within the assigned TA to include utilization and training requirements. The TA Safety Manager supports the adherence to Good Pharmacovigilance Practice (GVP) and to other relevant Pharmacovigilance requirements across the organization.

Responsibilities

• Directs and oversees a team of assigned Safety Monitors Europe to implement Safety Monitoring activities and reach objectives.
• Contributes to the selection and drives onboarding, performance management, and personal development plans of new employees.
• Supervises maintenance and execution of mandatory training curriculums of direct reports.
• Coordinates or personally performs safety monitoring activities in cooperation with project Medical Monitor.
• Reviews safety events.
• Oversees the collection, assessment, monitoring, review, and reporting of adverse drug reaction cases from all sources.
• Provides first line evaluation of serious adverse events (SAEs).
• 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 Data Safety Monitoring Board (DSMB) reports, regulatory submissions, and final study reports.
• Coordinates the timely completion and submission of required reports to health authorities and business partners.
• Maintains ongoing database of SAEs and reconciles SAEs in the database as needed.
• Reviews adverse events for the study on a regular basis.
• Establishes direct communication with Client, investigator site staff, national and regional regulatory authorities, health professionals, pharmaceutical and other study partners, as necessary.
• Responds to site, Client, pharmaceutical partner requests for information regarding safety in clinical trials.
• Participates in 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 for the planning, preparation, and development of all safety related sections of protocols, study specific safety documents.
• Contributes to the development and implementation of the safety Case Report Forms (CRF) and Safety Monitoring Plans (SaMP).
• Ensures maintenance of documentation required by corporate and project SOPs.
• Participates in project process improvement and corporate quality assurance activities.
• Performs Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug coding, as applicable.
• Coordinates close cooperation between PVOs and other Emmes roles.
• Ensures that all documentation relevant for the assigned project is always audit/inspection ready.
• Enforces that the delivery of services to the specific Client is regularly monitored and invoiced in a transparent way.
• Represents Emmes in case of audit or inspection directly or indirectly related to the specific PV project.
• Guarantees compliance and adherence to the quality standards.
• Contributes to the development and maintenance of departmental quality documents.
• Directs other corporate activities including annual SOP reviews, development and teaching of Emmes classes.
• Coordinates close cooperation between Safety Monitors and other Emmes roles.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelor's degree in pharmacology, nursing or other scientific discipline is required with relevant experience in clinical practice.
• 7-9 years in clinical practice, research, or pharmaceutical medicine with 3 years' experience in safety monitoring/pharmacovigilance.
• 1-3 years mentorship and/or managerial experience, including PV project management.
• Understanding of clinical drug development.
• Knowledge of clinical trial associated pharmacovigilance services.
• Knowledge of Good Clinical Practice and Good Pharmacovigilance Practice.
• 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.
• Excellent oral and written communication skills.
• Ability to work as a team member and function on a cross functional team.

Benefits

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment