Apply knowledge and expertise in the area of safety aggregate and benefit risk management documents. Serve as principal owner of Safety Aggregate Reporting and Analytics (SARA) and Benefit Risk Management (BRM) deliverables and mentor less experienced staff.
Contribute knowledge and expertise to or lead assigned deliverables in the field of SARA and BRM.
Serve as principal owner of SARA or BRM deliverable and have responsibility for completion of the document in compliance with all applicable service level agreement s.
Prepare each version of the 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.
Lead medium to large projects to ensure all activites are completed on time and meet quality standards.
Attend internal and customer project team meetings (face-to-face, online or via teleconference) as defined in the scope of work (SOW) and budget. May also serve as the Program Lead (where there are multiple SARA projects within the same programs) or the customer representative/relationship manager (if identified). Address all review comments by both internal and external stakeholders.
Chair planning meetings, data interpretation meetings, online documents review meetings, as required.
Build a positive, collaborative team environment with SARA team members, lead by example, provide training and mentoring for less experienced team 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
Prepare function-specific responses to regulatory authority requests and function-specific responses to assessment reports from regulatory authorities, if required
Provide mentorship and training to less experienced resources.
Mentor new project leads.
Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns; participate in project review meetings with management; communicate and document project issues to project team members and department management in a timely manner; complete regulatory reports.
Ensure compliance to Quintiles high quality standards and works with LSM, Medical and BRM constructively in a matrix framework to achieve project and customer deliverables.
Participate in training across Lifecycle safety process service offerings, participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.
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
In depth knowledge and 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, SOPs.
Proven ability to meet strict deadlines; manage competing priorities.
Demonstrate effective project management and leadership skills.
Sound judgment; independent thinking and decision making skills.
Demonstrate a flexible and receptive approach to changing demands.
Proven ability to work independently and autonomously with policies and practices.
Effective mentoring and coaching skills.
Excellent attention to detail and accuracy maintaining consistently high quality standards.
Ability to multitask and prioritize Excellent organizational skills and time management skills.
Excellent written/verbal communication and report writing skills.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Ability to work effectively on multiple projects simultaneously organize own workload and effectively manage competing priorities.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s Degree in a Health Science and 3 years’ experience of Safety (Pharmacovigilance, Medical Information, Safety Publishing or Risk Management, etc.) or equivalent combination of education, training and experience.
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
May require occasional travel.
USA-North Carolina-Research Triangle Park
USA02 - US Clinical Development Svcs
Quintiles Transnational has plenty to CRO about. One of the world's top contract research organizations (CROs), it...