IQVIA Released Job Openings On 19/05/2022.The Company offers commercial, physical, and biological research and development services, as well as value-based analyses, research studies, clinical management analytics, and health outcome optimization services.Application form link provided at the end of post. Eligibility for the Safety Aggregate Report Specialist as follows.
Vacancy Details:
IQVIA Recruiting B.Pharma,M.Pharma,M.sc,BHMS,B.U.M.S candidates with 03+ Years Experience for Safety Aggregate Report Specialist Position.Complete Details for the Safety Aggregate Report Specialist as follows.
Important Details :
- Location : Kochi/Cochin, Ahmedabad, Gurgaon/Gurugram, Bangalore/Bengaluru, Mumbai (All Areas) (WFH during Covid)
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application:19/05/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Related Job: Tata Consultancy Services(TCS) Looking For B.Sc, B.Pharm,M.Pharm,B.Com,BA,BCA FRESHERS
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Job Description/Skills Required
- 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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