Multiple Vacancies in Pharmacovigilance at IQVIA

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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.

Safety Associate 1 (Location Kochi, Kerala)

Job description
Job Overview
Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members

Essential Functions
• 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/ projecttimelines.
• 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.
• 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.
• 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.

Candidate Profile
Minimum with 1-2 years of experience in Pharmacovigilanceare eligible
• Good knowledge of medical terminology
• Working knowledge of applicable Safety Database
• Knowledge of applicable global, regional, local clinical research regulatory requirements
• Excellent attention to detail and accuracy
• Good working knowledge of Microsoft Office and web-based applications
• Strong organizational skills and time management skills
• Strong verbal/written communication skills
• Self-motivated and flexible
• Ability to follow instructions/guidelines, utilize initiative and work independently
• Ability to multi-task, manage competing priorities and deadlines
• Ability to delegate to less experienced team members
• Willingness and aptitude to learn new skills across Safety service lines
• 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
• Ensure quality of deliverables according to the agreed terms
• Demonstration of IQVIA core values while doing daily tasks
• Extensive use of keyboard requiring repetitive motion of fingers.
•Exte nsive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• May require occasional travel.

Operation Specialist 1 (Location Kochi, Kerala)

Job description
Job Overview
Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.

Essential Functions
• 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.

Candidate Profile
Minimum with 2.6-5 years of experience in Pharmacovigilanceare eligible
• Good knowledge of medical terminology
• Working knowledge of applicable Safety Database and any other internal/Client applications.
• Knowledge of applicable global, regional, local clinical research regulatory requirements
• Excellent attention to detail and accuracy; maintain high quality standards
• Good working knowledge of Microsoft Office and web-based applications
• Strong organizational skills and time management skills
• Strong verbal/written communication skills
• Self-motivated and flexible
• Ability to follow instructions/guidelines, utilize initiative and work independently
• Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands
• Ability to delegate to less experienced team members
• Ability to be flexible and receptive to changing process demands.
• Willingness and aptitude to learn new skills across Safety service lines
• 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
• Ensure quality of deliverables according to the agreed terms
• Demonstration of IQVIA core values while doing daily tasks
• Extensive use of keyboard requiring repetitive motion of fingers.
• Exte nsive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• May require occasional travel.

Associate Manager, Safety Operations (Location Kochi, Kerala)

Job description
Job Overview
Manage Safety staff responsible delivering services in Safety Operations under the guidance of senior management. May contribute to Global initiatives. Work in close collaboration with Senior Management and other relevant stakeholders supporting the achievement of local and global deliverables and metrics.

Essential Functions
• 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.

Candidate Profile
Minimum with 7.5 -10 years of experience in Pharmacovigilancewith 1.6 years of lead exp is a must.
• 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.
• Exte nsive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• May require occasional travel.

Manager, Safety Operations (Location Kochi, Kerala)

Job description
Job Overview
Manage Safety staff responsible for Safety Operations processing in alignment with departmental and corporate standards. Contribute to Global initiatives. Work in close collaboration with SM and other relevant stakeholders supporting the achievement of local and global deliverables and metrics.

Essential Functions
• 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.

Candidate Profile
• 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
• In-depth knowledge of Safety service lines; willingness to increase knowledge across Safety service lines and develop new skills.
• Proven Staff management skills, strong leadership, motivational and influencing skills.
• Ability to work on multiple projects and manage competing priorities.
• Effective mentoring and developed coaching skills.
• Excellent 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.
• Exte nsive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• May require occasional travel.

Additional Information
Experience : 1-12 year
Location : Kochi, Kerala
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 15th September, 2020

Safety Associate 1

Operations Specialist 1

Assoc. Manager, Safety Operations

Manager, Safety Operations

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