Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Post: Safety Aggregate Reporting Specialist-1503184
Job Description
Apply knowledge and contribute to individual deliverables in the field of Safety Aggregate Reporting and Analytics (SARA).
RESPONSIBILITIES
* Comply with all applicable service level agreements for SARA deliverables.
* Serve as principal owner of the SARA deliverable and have responsiblility for completion of the document in compliance with all applicable service level agreement s.
* Prepare each version of the Safety Aggregate Reporting and Analytics deliverable and maintain version control of the document. Request source documents from other Quintiles departments or customers. May also request example documents, style guide and other documents (e.g., signal analyses, regulatory correspondence) as deemed necessary. Address all review comments by both internal and external stakeholders.
* Attend internal and customer project team meetings (face-to-face, online or via teleconference) as defined in the scope of work (SOW) and budget. Attend planning meetings, data interpretation meetings, online documents review meetings, as required.
* Perform delegated lead activites with supervision. Lead small projects and ensure all activites are completed on time and meet quality standards
* Mentor less experienced or newer staff members.
* Work closely with case processing service operations to resolve issues, if any.
* Interface with other functional groups, such as Regulatory Affairs, Clinical/Medical Affairs functions, Quality, Information Technology, or other business units as needed
* Assist in preparation of function-specific responses to regulatory authority requests and of function-specific responses to assessment reports from regulatory authorities, if required
* Lead or participate in project teams and committees as assigned. Initiate new projects to improve processes
* 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. Work towards ensuring your individual training plan and training transcript are reconcilable.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
* Excellent knowledge of One Q Safety services and processes; willingness and aptitude to learn new skills across One Q Safety service lines.
* Good understanding of applicable global, regional, local clinical research 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 changing demands.
* Proven ability to follow instructions/guidelines, work independently and on own initiative.
* Good understanding of operational metrics, productivity and initiatives.
* Excellent attention to detail and accuracy and maintain consistently high quality standards.
* Effective mentoring skills.
* Excellent written and verbal communication and report writing skills.
* Ability to be flexible and receptive to changing process demands.
* Sound judgment; decision making skills.
* Ability to work effectively on multiple projects simultaneously. Organize own workload and effectively time manage competing priorities.
* Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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MINIMUM REQUIRED EDUCATION AND EXPERIENCE
* Bachelor’s Degree or educational equivalent in a Scientific or Healthcare discipline and 1 year’s experience of Safety (Pharmacovigilance, Medical Information, Safety Publishing or Risk Management, etc.)
Qualifications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor’s Degree or educational equivalent in a Scientific or Healthcare discipline and minimum 1.5 years aggregate reporting experience must. Exp in Pharmacovigilance, Medical Information, Safety Publishing or Risk Management, etc.) or equivalent combination of education, training and experience.
Additional Information:
Experience: 1-2 years
Location: Karnataka-Bangalore
Last Date: 11th June, 2015
Id: 1503184
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