IQVIA RDS India Pvt Ltd Hiring 2022 B.Pharma/ M.Pharma/M.sc for Safety Aggregate Report Specialist At Kochi/Cochin, Ahmedabad, Gurgaon/Gurugram, Bangalore/Bengaluru, Mumbai (All Areas) (WFH during Covid) . IQVIA RDS India Pvt Ltd Notification full details below..Interested and eligible candidates can Apply Now.
- Vacancy details:
- Post Name: Safety Aggregate Report Specialist
- Qualification: B.Pharma/ M.Pharma/M.sc
- Experienced:03 to 8 years
Job Description: IQVIA RDS India Pvt Ltd Hiring For Safety Aggregate Report Specialist !
- Important Details :
- Location: Kochi/Cochin, Ahmedabad, Gurgaon/Gurugram, Bangalore/Bengaluru, Mumbai (All Areas) (WFH during Covid)
- Post of date: 18/05/2022
- Selection Process: The selection will be on the basis of Interview.
Roles and Responsibilities
JOB DESCRIPTION PURPOSE Apply knowledge and contribute to Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, and signal management activities. RESPONSIBILITIES Serve as principal owner of the SARA deliverable and have responsiblility for completion of the deliverable in compliance with all applicable service level agreements. Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs, DSURs, PADERs, ACOs, and six monthly line listings; author responses to regulatory agency/PRAC inquiries, as required. Contributes in the conduct of ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Provide assistance in signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked. Interface with other functional groups within Lifecycle Safety and other business units, such as Regulatory Affairs, RWLP, Medical Writing, Clinical Research, Quality, and Information Technology, as needed. Participate in internal and external audits, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Excellent knowledge of Lifecycle Safety services and processes; willingness and aptitude to learn new skills across Lifecycle Safety service lines. Good understanding of applicable global, regional, local regulatory requirements; i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs). Proven ability to meet strict deadlines; manage competing priorities and ability to be flexible and receptive to changing demands. Excellent organizational skills and time management skills. Proven ability to follow instructions/guidelines, work independently and on own initiative. Excellent attention to detail and accuracy and maintain consistently high quality standards. Excellent written and verbal communication and report writing skills. Sound judgment; independent thinking and decision making skills. Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelors Degree or educational equivalent in a Scientific or Healthcare discipline and 5 to 6 years experience of drug safety or 3 years safety scientist coordinator and minimum 2 year or more experience in aggregate reporting or equivalent combination of education, training and experience.
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