Description
fDescription:
POSITION SUMMARY:
The Sr. Clinical Safety Manager is accountable for the day-to-day functioning and performance of safety activities of the Pharmacovigilance and Safety department.
ESSENTIAL JOB FUNCTIONS:
· Ensure that all safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements and SOPs and procedures.
· Perform Quality Control review of all cases to ensure accuracy, integrity and completeness of information entered in the CRO safety database.
· Ensure appropriateness of MedDRA and WHO-DD coding performed by CRO drug safety staff with input from Medical Monitor.
· Coordinate the submissions of expedited and non-expedited safety reports to regulatory authorities, partner companies and other organizations as needed.
· Oversee the set-up of new safety projects, including development of study-specific Safety Management Plan and set-up of study specific safety systems and processes (as needed).
· Manage vendor safety reporting activities including quality assurance.
· Participate in the planning and preparation of the adverse event section of protocols for studies and review of CRFs (as necessary).
· Support the Clinical Operation teams with respect to safety related issues as required.
· Participate in Clinical Team meetings and similar meetings representing Safety Department.
· Ensure that external investigators (e.g., ISTs, NCI) meet agreed upon safety reporting requirements to.
· Oversee preparation of the clinical sections of annual reports, and periodic safety reports.
· Oversee reconciliation of safety database with clinical database for a given study.
· Provide expert guidance on regulations and their impact on Safety management processes and procedures.
· Manage the Safety Review Committee with input from CMO, ensuring that agendas and materials and minutes are generated for quarterly meetings.
· Participate in the development and management of Data Monitoring Committees, including development of DMC charters (as needed) and ensuring that activities/listings for DMC meetings are completed in a timely manner and meeting outcomes are documented as needed for requests from IRBs/ECs and/or regulatory authorities.
· Develop, manage and implement departmental policies and SOPs.
· Performs other duties in Clinical Operations as requested by VP, Development Operations.
Requirements:
· Strong organizational, management, teamwork, interpersonal skills and professionalism required.
· Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
· Outstanding communication skills (verbal and written).
· Focus on detail with enthusiasm to constantly seek ways to improve processes and practices.
· Ability to manage multiple projects in a fast-paced environment.
· Collaborate effectively with the study team, cross-functional team members, and external partners.
· Previous Pharmacovigilance / Drug safety experience of at least 3-5 years in a global environment.
· At a minimum, Bachelor's level degree in life sciences, pharmacy, nursing or RN. Master's Degree or PharmD preferred.
· Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environments.
· Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
· Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed.
· Familiarity with common Safety databases (e.g., Aris, AERS, Argus, etc.) preferred.
· Travel may be required.
To find out more about Real please visit www.realstaffing.com