Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Case Processing Team Lead
Position Purpose
• Develop and maintain knowledge of applicable SOPs and the Argus User Reference Guide.
• Develop and maintain current knowledge of products within the Pfizer portfolio
• Maintain working knowledge of applicable corporate and global regulations/guidelines.
• Develop an understanding of the importance of ICSR processing to aggregate report quality and timeliness.
• Contribute to ‘Right First Time’ initiatives.
Primary Responsibilities
• In the absence of the Case Processing Cluster Team Lead, act as point of contact for the Case Processing Cluster.
• Manage the case-flow process to ensure timely and accurate processing of adverse event cases to meet corporate and regulatory reporting requirements.
• Provide oversight and guidance to Safety Surveillance Associates and Safety Surveillance Specialists on review and processing of adverse event reports.
• Manage the team’s case processing to ensure complete and timely submission to the PSSR aggregate reports group.
• In cooperation with the Case Processing Head, Case Processing Cluster Team Leads, and Business Planning Leads, manage available resources to ensure effective processing of PSSR caseload, processing cases when necessary.
• Take responsibility for identifying the root causes of- and implementing the corrective actions for timeliness or quality issues associated with case processing. Primary Responsibilities
• In the absence of the Case Processing Cluster Team Lead, act as point of contact for the Case Processing Cluster.
Technical Skill Requirements
• Strong interpersonal skills, with a demonstrated ability to manage people and foster teamwork.
• Demonstrable understanding of safety report processing and assessment of safety at the Senior Safety Surveillance Associate level; ability to process cases an advantage.
• Ability to meet personal objectives while meeting departmental standards of performance.
• Demonstrable skills in project, time and change management, organizational and facilitation skills.
• Good understanding of medical terminology and familiarity with principles of clinical assessment of safety reports in the context of an international pharmaceutical industry.
• Knowledge of global regulations governing safety reporting.
• Demonstrated computer literacy, particularly in the use and management of relational databases.
• Demonstrable organizational and time management skills, in order to meet strict regulatory compliance goals.
• Good oral and written communication skills, with fluency in spoken and written English; knowledge of additional language(s) an advantage.
Candidate Profile
Bachelor’s degree in a science-related field, pharmacy or nursing or equivalent, advanced degree an advantage.
Minimum of three years research, clinical or equivalent experience in the pharmaceutical industry; managerial experience in hospital or pharmacy, and familiarity with clinical assessment is highly desirable.
Additional Information
Experience : 3 years
Qualification : BSc, B.Pharm
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Case Processing
End Date : 10th April, 2021
See All Chennai Alerts B.Pharm Alerts M.Pharm Alerts M.Sc Alerts
See All Other Jobs in our Database
.png)
