Safety Associate

5 months ago

Bengaluru, India Novasyte Full time

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 Standard Operating Procedures (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 IQVIA 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.
- Lead/ Support department Initiatives
- 100% compliance towards all people practices and processes
- In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications.

**Qualifications**:

- High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req
- Bachelor's degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience. Req
- or equivalent combination of education, training and experience. Pref
- Good knowledge of medical terminology. Intermediate
- Knowledge of applicable global, regional, local clinical research regulatory requirements. Intermediate
- Excellent attention to detail and accuracy. Intermediate
- maintain high quality standards. Intermediate
- Strong organizational skills and time management skills. Intermediate
- Strong verbal/written communication skills. Intermediate
- Self-motivated and flexible. Intermediate
- Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate
- Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands. Intermediate
- Ability to delegate to less experienced team members. Intermediate
- Ability to be flexible and receptive to changing process demands. Intermediate
- Willingness and aptitude to learn new skills across Safety service lines. Intermediate
- Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate
- Ability to work as a Team Player, contribute and work towards achieving Team goals. Intermediate
- Ensure quality of deliverables according to the agreed terms. Intermediate
- Demonstration of IQVIA core values while doing daily tasks Advanced
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate
- Regular sitting for extended periods of time. Intermediate
- May require occasional travel. Intermediate
- Flexibility to operate in shifts. Intermediate

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We

  • Associate Safety Operations Advisor

    5 months ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Associate safety operations advisor **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**: Global Safety.- **About the Department** - Global Safety, Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical development and marketed Products and is responsible for...

  • Associate Safety Operations Adviser

    5 months ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Associate Safety Operations Adviser **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**: Global Safety.- **About the Department** - Global Safety, Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical development and marketed Products and is responsible for...

  • Associate Safety Operations Advisor

    5 months ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Associate Safety Operations Advisor **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**: Global Safety.- **About the Department** - Global Safety, Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical development and marketed Products and is responsible for...

  • Associate Safety Operations Adviser

    5 months ago

    Bengaluru, India Novo Nordisk Full time

    **Department**: Global Safety. **About the Department** Global Safety, Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical development and marketed Products and is responsible for global handling and reporting of adverse events reports. **The Position** All tasks in the GS-GBS SO Safety Operations Advisers...

  • WHS Safety Specialist

    4 days ago

    Bengaluru, Karnataka, India ASSPL - Karnataka Full time

    About the RoleThe Site WHS Officer will be responsible for partnering with the site operations team in a Sort Center to execute company safety policies and ensure compliance to all applicable local and regional regulations.Key ResponsibilitiesLeads continuous improvement initiatives to reduce conditional and ergonomic risk in our processes to ensure a safe...

  • Safety Manager for India Operations

    3 days ago

    Bengaluru, Karnataka, India Fluence Full time

    About the RoleWe are seeking a highly skilled and experienced Safety Manager for India Operations to join our team at Fluence. As a key member of our Global Innovation Centre, you will be responsible for developing and maintaining occupational health and safety policies and programs for our Corporate Safety Operations, GIC, and associated regional...

  • Safety Assurance Engineer

    4 days ago

    Bengaluru, Karnataka, India Alstom Full time

    About the RoleWe are seeking a highly skilled Safety Assurance Engineer to join our team at Alstom. This is an exciting opportunity to work on high-profile projects and contribute to the development of cutting-edge safety solutions for the rail industry.Main ResponsibilitiesCoordinate all safety assurance activities on CBTC systems for projects, ensuring...

  • WHS Officer

    1 week ago

    Bengaluru, Karnataka, India ASSPL - Karnataka Full time

    About the RoleThe Site WHS Officer will be responsible for partnering with a site operations team in a Sort Center to execute company safety policies and ensure compliance to all applicable local and regional regulations. This individual will lead continuous improvement initiatives to reduce conditional and ergonomic risk in our processes to ensure a safe...

  • Operations Safety Manager

    1 week ago

    Bengaluru, Karnataka, India Fluence Full time

    About the RoleWe are seeking a highly skilled Health and Safety Expert to join our team at Fluence. As a key member of our Transformation, Quality and Safety Department, you will play a critical role in the implementation of our corporate health and safety policies and programs.Key ResponsibilitiesProvide health, safety and environmental (HSE) subject matter...

  • Operations Safety Manager

    2 weeks ago

    Bengaluru, Karnataka, India Fluence Full time

    About the RoleFluence is seeking a highly skilled and experienced Health and Safety Specialist to join our team in India. As a key member of our Transformation, Quality and Safety Department, you will be responsible for providing health, safety, and environmental (HSE) subject matter expertise to support the implementation of our corporate health and safety...

  • Process Safety Specialist

    3 days ago

    Bengaluru, Karnataka, India Syngene Full time

    Job Title: Process Safety SpecialistJob Summary:Join a leader in the pharmaceutical industry as a Process Safety Specialist and play a key role in ensuring the safety of our employees, customers, and the environment.Responsibilities:Develop and implement process safety management systems to mitigate risks associated with chemical processes.Conduct risk...

  • Safety Assurance Manager

    2 weeks ago

    Bengaluru, Karnataka, India Alstom Full time

    Job Title: Safety Assurance Manager Job Summary: Alstom is seeking a highly skilled Safety Assurance Manager to lead the safety assurance activities for our CBTC Signalling Projects. The successful candidate will be responsible for ensuring the safety of our projects, managing safety risks, and developing safety plans. Key Responsibilities: * Coordinate...

  • Safety Assurance Specialist

    4 days ago

    Bengaluru, Karnataka, India Alstom Full time

    At Alstom, we are shaping the future of transportation by developing innovative solutions that promote sustainable mobility.Main Responsibilities:Coordinate Safety Assurance activities for CBTC Signalling Projects, adhering to defined Safety Process in Signalling Safety Instruction.Perform Safety analysis, manage Hazard Log, and review RAM, Cyber, V&V, T&C...

  • Associate/ Senior Associate

    4 months ago

    Bengaluru, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Primary Responsibilities Apply clinical judgement, critical thinking, and regulatory knowledge to the management of adverse event data within GPS systems to ensure data integrity, consistency, and compliance. Continuously expand knowledge of Lilly compounds /...

  • Safety Associate

    5 months ago

    Bengaluru, India IQVIA Full time

    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 Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team...

  • Safety Assurance Engineer

    3 weeks ago

    Bengaluru, Karnataka, India Alstom Full time

    Job Title: Safety Assurance EngineerAlstom is seeking a highly skilled Safety Assurance Engineer to join our team in the CBTC Signalling Projects department. As a key member of our team, you will be responsible for ensuring the safety of our signalling systems and products.Key Responsibilities:Manage and perform safety assurance activities on CBTC systems...

  • Safety Assurance Manager

    3 days ago

    Bengaluru, Karnataka, India Alstom Full time

    Alstom is seeking an experienced Safety Assurance Manager to lead the safety assurance activities for our CBTC Signalling Projects.Main Responsibilities:Coordinate all safety assurance activities on the CBTC System for Projects as per Safety process defined in Signalling Safety Instruction.Perform safety analysis, manage Hazard Log, review RAM, Cyber, V&V,...

  • WHS Officer

    3 weeks ago

    Bengaluru, Karnataka, India ASSPL - Karnataka Full time

    Job SummaryThe Site WHS Officer will be responsible for partnering with a site operations team in a Sort Center to execute company safety policies and ensure compliance to all applicable local and regional regulations. By leveraging lean principles and kaizens, this individual will lead continuous improvement initiatives to reduce conditional and ergonomic...

  • Operations Safety Manager Role

    6 days ago

    Bengaluru, Karnataka, India Fluence Full time

    About the RoleWe are seeking a dedicated and experienced Health, Safety, and Environment (HSE) professional to join our team in India as an Operations Safety Manager. In this role, you will be responsible for providing HSE subject matter expertise to support the implementation of our corporate health and safety policies and programs.Key...

  • Safety Assurance Engineer

    2 hours ago

    Bengaluru, Karnataka, India Alstom Full time

    Job SummaryWe are seeking a skilled Transportation Safety Specialist to join our team at Alstom, a leading company in the mobility sector. This role involves managing and performing safety assurance activities on CBTC Signaling Projects, ensuring the delivery of safe solutions and adhering to regulatory requirements.Key ResponsibilitiesCoordinate safety...