Description
Drug Safety ManagerThe Drug Safety Manager will support the client Drug Safety Department as an interdepartmental project lead in the handling and analyses of safety data from clinical trials and spontaneous post-marketing reports. The Manager will work closely with the assigned project lead to facilitate and meet client project deadlines. This will include such activities as oversight and management of Drug Safety Associate staff, ensuring timely reporting of SAEs to Regulatory Authorities and cross-reporting to pharmaceutical partner(s). The Project Manager will also ensure that all adverse event information is handled in a manner consistent with departmental standard operating procedures as well as federal and international regulations.
The Drug Safety Manager will also participate in development, implementation and maintenance of quality systems for all Drug Safety activities, encompassing processes, procedures, compliance and metrics; additionally, the Manager will support the management of other employees with a working knowledge of employee policies and procedures.
Drug Safety Manager Responsibilities:
The major duties and responsibilities will include but are not limited to the following:
- Oversee individual projects as assigned within the client drug safety setting
- Provide directional support to Drug Safety Associate staff
- Draw on knowledge of Drug Safety, disease specific clinical knowledge and understanding of the companies objectives to solve complex problems in creative and effective ways, as well as to anticipate routine problems and mitigate them without supervisory intervention
- Maintain a high level of understanding of federal and international regulations and guidances in order to guide departmental policies and procedures
- Provide guidance and mentoring when appropriate to other team members in the performance of their job, including day to day case processing activities
- Evaluate project case workflow and offer solutions for process improvement
- Maintain regulatory and department compliance by ensuring timely completion of client reports and facilitating submissions of reportable cases to regulatory agencies, study investigators, licensing partners and CROs
- Participate in the preparation of client aggregate safety reports such as Periodic Adverse Drug Experience Reports (PADER), Periodic Safety Update Reports (PSUR), quarterly safety reports to Ethics Committees, and annual reports to regulatory authorities
- Process SAE and AE reports of client marketed and investigational products in accordance with all applicable regulations, guidelines including client Safety Management Plans, and SOPs with little or no supervision. This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check
- ·Conduct periodic reconciliation of SAEs between the client drug safety and clinical trial databases for ongoing clinical studies
- ·Represent the Drug Safety Department in client cross-functional team meetings
- Draft and update client and company departmental SOPs and other work practices as assigned to be consistent with regulatory guidelines and good pharmacovigilance practices. Participate in regular audits of department SOPs
- Draft drug safety documents, such as client Safety Management Plans for client clinical studies or postmarketed products, and development of various forms as required, such as Clinical Study Reporting Forms
- Maintain an awareness of allocated project resource utilization and make appropriate recommendations to company project lead as required
- ·Participate in training of drug safety staff and internal and external client audiences on drug safety related topics, such as investigator meetings as required
Drug Safety Manager Requirements:
- Typically requires a BS degree in a life science discipline, e.g., pharmacy, nursing, and a minimum of 6 years of relevant experience which includes 4 years in drug safety
- Broad knowledge of domestic and international drug safety regulations, industry practices and standards
- Working knowledge with at least one major safety database system (e.g., Argus, ARIS-g, Oracle AERS, E-Trace)
- Strong attention to detail, teamwork and initiative
- Excellent written and oral communication skills, resourcefulness and personal organization skills
- Excellent working knowledge of MedDRA and WHODRUG coding dictionaries.
- Proficient in Microsoft Word, Power Point, and Excel; experience with Microsoft Visio helpful
- Strong interest in managing people and projects
If you are interested in applying to this role, please respond to this job posting ASAP as we are looking to fill this position immediately.
To find out more about Real please visit www.realstaffing.com