北京招聘

PURPOSE

Obtain and process adverse event (AE) data obtained in clinical trials and spontaneous reports according to applicable regulations and guidelines, standard operating procedures (SOPs), and project requirements. Lead small (up to and ocassionally greater than 100 AEs) clinical, Clinical Event Validation and Adjudication (CEVA) or post-marketing safety projects ensuring all activities are completed on time, within budget and meet quality standards.

RESPONSIBILITIES

• Receive and document incoming telephone calls or faxes from investigative sites or other sources reporting AEs, serious adverse events (SAEs) and spontaneous events; collect, track required data and enter into safety database, if applicable;
• follow up with sites to obtain missing data as required. Process data according to applicable regulations and guidelines, SOPs, and project requirements.
• Triage and classify incoming events; prioritze event case according to regulatory and project requirements.
• Ensure integrity and completeness of data according to applicable regulations and guidelines, SOPs and project-specific guidelines.
• Create complete, accurate and succinct narratives adhering to established project template. 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.
• Establish and maintain effective project communications by representing department at interdepartmental project team meetings, investigator meetings, and client meetings and by conducting productive internal department project team meetings.
• Track financial status of assigned projects; assist Project Manager with clinical safety-related change orders.
• Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns; communicate and document project issues to project team members and department management in a timely manner; with guidance, complete regulatory reports.
• Mentor less experienced/new staff members

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Master or Bechalor degree of Pharmacy or related educational background
• Strong motivation in drug safety area
• Working knowledge of AE processing, CEVA and Post Marketing requirements
• Working 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 SOPs
• Strong organizational skills with the ability to meet strict deadlines
• Skill in use of multiple safety databases
• Basic project management skills
• Demonstrate a positive and flexible working attitude
• Effective presentation and report writing skills
• Effective team building skills
• Effective telephone etiquette skills
• Excellent verbal and written communication skills
• Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
 
If that is your passion, we have a place for you.