Drug safety manager

Job Title :Drug safety manager
Department  :
Report To :
Subordinate :N/A
Promotion :
Sensitivity :Sensitive, NDA is a must
Location :Shanghai / Beijing

Establish and maintain a thorough understanding of project protocol, budget and scope of work (SOW) for assigned projects; set up and maintain project materials such as project files, forms, templates, databases and workflow.
Build a positive, collaborative team environment with project team members; provide training and mentoring for project team members and department staff; assist management with allocating resources to projects.
Establish and maintain effective project communications by representing department at interdepartmental project team meetings, investigator meetings and by conducting productive internal department project team meetings; provide global coordination of departmental activities.
Participate in internal audits for assigned projects. Liaise with Quality Assurance staff and overall management in the compilation of CAPs.
Track financial status of assigned projects; assist Project Manager with clinical related change orders. Attend and represent assigned projects at financial meetings.
Provide comprehensive feedback on project team members for input into appraisals. Provide consistent and frequent feedback to department managers on staff quality and progression.
Provide regular reports to overall project manager and department management on project metrics, SOW changes; participate in project review meetings with management; communicate and document project issues to project team members and department management in a timely manner; complete regulatory reports.
Drive case follow-up and closure processes; process cases as needed.
Assist senior leaders in managing department by identifying, developing and implementing new processes and systems designed to improve quality and efficiency, updating managers on new regulations, representing department at sales, marketing, bid defense and other extra-departmental meetings, creating and modifying SOPs and work instructions (WIs).
Obtain and process adverse event (AE)/ICSR/endpoint data obtained in clinical trials or post marketing projects according to applicable regulations and guidelines, standard operating procedures (SOPs), and project requirements.

Job Requirements
In-depth knowledge of event processing and Clinical Event Validation and Adjudication in both clinical and post marketing areas.
In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
In-depth knowledge of departmental standard operating procedures (SOPs).
Skill in use of multiple safety databases.
Strong project management skills.
Strong coaching and team building skills.
Excellent written communication skills.
Ability to lead projects within strict deadlines.
Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities.
Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff and regulatory agency representatives.