Multiple Vacancies in Pharmacovigilance at IQVIA

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Operations Specialist 1
Requisition Number : R1134675
Experience Required : Minimum with 2.6-5 years of experience in Pharmacovigilance are eligible.
• To Prioritize and complete the assigned trainings on time.
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information; determining initial/update status of incoming events; database entry; coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
• Ensure to meet quality standards per project requirements.
• Ensure to meet productivity and delivery standards per project requirements.
• To ensure compliance to all project related processes and activities.
• 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.
• Creating, maintaining and tracking cases as applicable to the project plan.
• Identify quality problems, if any, and bring them to the attention of a senior team member.
• To demonstrate problem solving capabilities.
• Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
• May liaise with client in relation to details on day to day case processing activities.
• To mentor new teams members, if assigned by the Manager.
• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
• Perform other duties as assigned.
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Operations Specialist 2
Requisition Number : R1134679
Experience Required : Minimum with 5-7 years of experience in Pharmacovigilance are eligible.
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information; determining initial/update status of incoming events; database entry; coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.
• Perform activities related to adjudication as applicable
• Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting. Liaise with manager for regulatory tracking requirements and electronic reporting.
• Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
• Ensure to meet quality, productivity and delivery standards per project requirements.
• Ensure compliance to all project related processes and activities.
• Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed.
• Provide and impart technical and process information to Safety Management and members of operational team on project specific issues.
• Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
• Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement.
• Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes; effective feedback on project performance to junior members of team.
• 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 completeness of individual training plan and maintain upto date training transcripts.
• Participate in training across Safety process service offerings; participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.
• To demonstrate problem solving capabilities.
• Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
• Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes.
• To liaise with client in relation to details on day to day activities as needed.
• Contribute to achievement of departmental goals
• Perform other duties as assigned.
• Excellent knowledge of medical terminology
• In depth knowledge and understanding of applicable Safety Database and any other internal/Client applications.
• In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements
• Excellent organizational skills, time management skills, attention to detail and accuracy; maintain high quality standards
• Excellent working knowledge of Microsoft Office and web-based applications
• To demonstrate effective project management and leadership skills.
• Effective mentoring and coaching skills.
• Excellent verbal/written communication skills
• Self-motivated, flexible, receptive to changing process demands; willingness and aptitude to learn new skills across Safety service lines.
• Proven ability to work independently and autonomously with policies and practices.
• Proven ability to multi-task, meet strict deadlines, manage competing priorities
• Ability to identify, prioritize tasks and delegate to team members
• Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients
• Ability to work as a Team Player, contribute and work towards achieving Team goals
• Demonstrate Sound judgment and decision making skills.
• Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams’ priorities.
• Ensure quality of deliverables according to the agreed terms
• Demonstration of IQVIA core values while doing daily tasks
• Skill to plan work load based on available capacity and ability to change prioritization based on workload fluctuations.
• Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders.
• 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.
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Assoc. Manager, Safety Operations
Requisition Number : R1134677
Experience Required : Minimum with 7 - 8.5 years of experience in Pharmacovigilance with 1.6 years of lead exp is a must.
• Implement and support operational decisions as determined and instructed by senior management. May contribute and assist in global initiatives e.g. Change Management; Subject Matter Expert (SME) Committees; SOP Review Committees; Retention, Engagement, training, processes etc.
• Assist in the implementation for measuring and improving employee engagement local and/or global actions. Maintain open and regular communication with direct reports to ensure a supportive working environment.
• Supervise Safety Operations staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; performance appraisal and professional development guidance; rewarding and disciplining employees; addressing employee relations issues; resolving problems and absence management. Approve actions on human resources matters.
• Support the management on project resource assignments, staff hiring and staff terminations in collaborations with operations specialist managers. Assists with staff training; professional and career development.
• Work closely with operations managers to address problem areas, work scheduling for current and projected projects, and projected peak workloads. Monitor, assess and report utilization of staff. Identify and implement solutions to address poor utilization.
• Ensure direct reports are cross trained on Safety service offering as applicable; monitor and develop training plans; identify training and development needs of staff in collaboration with Training team and Safety Management.
• Lead and encourage direct reports in continuous improvement of department work processes, procedures and infrastructure. Instruct and lead direct reports in efficient management of project budgets through effective timesheet reporting. Work closely with operations specialist managers.
• Monitor and ensure that project processes and department deliverables meet expected quality, financial and productivity targets. Assist with meeting department utilization and realization targets.
• Ensure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA regulations and guidelines, work instructions and client expectations.
• Ensure that staff have been trained on and are following required Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), FDA and ICH guidelines and regulations, Work Instructions and project instructions.
• Work with Safety Management constructively in a matrix framework to achieve project and customer deliverables.
• Perform other duties as assigned.
• Sound knowledge of Safety service lines; willingness to increase knowledge across Safety service lines and develop new skills.
• Staff management skills, effective leadership, motivational and influencing skills.
• Ability to work on multiple projects and manage competing priorities.
• Ability to mentor and coach.
• Strong presentation, report writing skills and customer focus skills.
• Ability to achieve results through communication and facilitation in a matrix service delivery environment with shared accountabilities.
• Sound judgment, decision-making and problem solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• 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.
• Ensure quality of deliverables according to the agreed terms
• Demonstration of IQVIA core values while doing daily tasks
• Skill to plan work load based on available capacity and ability to change prioritization based on workload fluctuations.
• Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders.
• 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.
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Manager, Safety Operations
Requisition Number : R1135167
Experience Required : Minimum with 9-11 years of experience in Pharmacovigilance with 4 years of lead exp is a must.
• Contribute and assist in global initiatives e.g. Change Management; Subject Matter Expert (SME) Committees; SOP Review Committees; Retention, Engagement, training, processes etc.
• Develop and implement plans for measuring and improving employee engagement ensuring global consistency. Maintain open and regular communication with direct reports to ensure a supportive working environment.
• Contribute to, implement and support operational decisions as determined and instructed by senior management.
• Manage Safety Operations staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; performance appraisal and professional development guidance; rewarding and disciplining employees; addressing employee relations issues; resolving problems and absence management. Approve actions on human resources matters.
• Management of project resource assignments, staff hiring and staff terminations in collaborations with operations specialist managers. Assists with staff training; professional and career development.
• Collaborate with other operations specialist’s managers to address problem areas, work scheduling for current and projected projects, staffing needs, equipment needs, and projected peak workloads, ensuring global consistency. Monitor, assess and report utilization of staff. Identify and implement solutions for poor utilization of staff, ensuring global consistency.
• Ensure direct reports are cross trained on Safety service offering; monitor and develop training plans; identify training and development needs of staff in collaboration with Training team and Safety Management.
• Lead and encourage direct reports in continuous improvement of department work processes, procedures and infrastructure. Instruct and lead direct reports in efficient management of project budgets through effective timesheet reporting. Work closely with operations specialist managers.
• Monitor and ensure that project processes and department deliverables meet expected quality, financial and productivity targets. Assist with meeting department utilization and realization targets.
• Ensure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA regulations and guidelines, work instructions and client expectations.
• Ensure that staff have been trained on and are following required Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), FDA and ICH guidelines and regulations, Work Instructions and project instructions.
• Work with Safety Management constructively in a matrix framework to achieve project and customer deliverables.
• Perform other duties as assigned.
• Bachelor's degree in life sciences or related field and upto 7 years of relevant experience, inclusive of upto 4 years of PV experience and upto 3 years of Line management experience; or equivalent combination of education, training and experience
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