143 Safety Director jobs in India

Job Overview
Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.

Essential Functions
• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
• Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
• Represent safety and clinical data review findings during client meetings
• Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
• Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
• Provide medical oversight for label development, review and change
• Provide medical support and attendance at Data Safety Monitoring Board Meetings
• Attends and contributes medical safety evaluation on Safety Monitoring Committees
• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
• Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments
• Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract
• Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
• Act as Global Safety Physician or Assistant or Back-up on projects as assigned
• Attend project meetings, medical safety team meetings, and client meetings as requested
• Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
• Provide medical escalation support for medical information projects
• Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
• 24 hour medical support as required on assigned projects
• Maintain awareness of medical-safety-regulatory industry developments

Qualifications
• Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req
• Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
• Knowledge of clinical trials and pharmaceutical research process
• Ability to establish and meet priorities, deadlines, and objectives.
• Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

Job Overview
Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.

Essential Functions
• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
• Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
• Represent safety and clinical data review findings during client meetings
• Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
• Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
• Provide medical oversight for label development, review and change
• Provide medical support and attendance at Data Safety Monitoring Board Meetings
• Attends and contributes medical safety evaluation on Safety Monitoring Committees
• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
• Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments
• Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract
• Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
• Act as Global Safety Physician or Assistant or Back-up on projects as assigned
• Attend project meetings, medical safety team meetings, and client meetings as requested
• Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
• Provide medical escalation support for medical information projects
• Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
• 24 hour medical support as required on assigned projects
• Maintain awareness of medical-safety-regulatory industry developments

Qualifications
• Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req
• Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
• Knowledge of clinical trials and pharmaceutical research process
• Ability to establish and meet priorities, deadlines, and objectives.
• Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

Greetings!

Position Title: Project Director ( expats only)

Client: One of the world's leading steel company

Job Location: Gujarat

Education Qualification: Minimum Bachelors in Engineering, Safety Qualification is desirable

Additional Safety Experience: Prior experience (at least 5 years) in working on Safety Culture Transformation projects

No. Of Years of Experience Required (min):

Minimum consulting exposure of 5 years, should have worked in large steel plant.

Overall Experience greater than 20 years

International Experience:

Preference for expats from the UK, Europe, Australia, middle east

Range:

45 - 55 years

Initial contract duration:

2 years, with a strong possibility of extension

Position Purpose :

The Project Director is responsible for the successful delivery of a comprehensive safety culture transformation project for a leading steel company with multiple business units across India. Initially based at the Gujarat site, with the possibility of incorporating additional small to mid-sized locations in the future, the Director will proactively plan, direct, and implement all aspects of the transformation program. This includes overseeing both construction safety activities and operational safety transformation program at the designated sites. The Project Director will be instrumental in fostering a strong safety culture by demonstrating exceptional leadership, communication, and engagement skills with the client and key stakeholders.

JOB DESCRIPTION :

Essential duties and Responsibilities:

• Engage client top management and resolve issues for effective implementation of safety at site.
• Manage the change and establish clear communication plan of the project.
• Communicate frequently about the project to the stakeholders (internal and external) via physical or digital communications.
• Reporting (Project roll out status, budget, capacity plan, Key Parameters), meeting minutes and challenges if any in regular and consistent manner.
• Promote best safety practices as a part of project implementation.
• Communicate timely to client on challenges and support required for effective project implementation.
• Review the program effectiveness / components and course correct, when required.
• Evaluate Project Managers and specialists team performance and provide feedback to Management (team size: 50 60 people).
• Organize platform for learning lessons and deploy learning in project.
• Manage construction safety and projects operational management at site.
• Actively engage with the client to understand their safety expectations, requirements and standards. Ensure these are integrated into the project safety management system.
• Collaborating with Client for safety planning, ensuring that all safety protocols are adhered to and fostering a culture of safety across the site.
• Foster a culture of safety consciousness among all project stakeholders, encouraging a proactive approach towards safety.
• Organize and lead committee meetings, and discuss safety performance, challenges and strategic decisions.

Greetings!Position Title: Project Director (expats only)Client: One of the world's leading steel companyJob Location: GujaratEducation Qualification: Minimum Bachelors in Engineering, Safety Qualification is desirableAdditional Safety Experience: Prior experience (at least 5 years) in working on Safety Culture Transformation projectsNo. Of Years of Experience Required (min):Minimum consulting exposure of 5 years, should have worked in large steel plant.Overall Experience greater than 20 yearsInternational Experience:Preference for expats from the UK, Europe, Australia, middle eastRange:45 - 55 years Initial contract duration:2 years, with a strong possibility of extensionPosition Purpose:The Project Director is responsible for the successful delivery of a comprehensive safety culture transformation project for a leading steel company with multiple business units across India. Initially based at the Gujarat site, with the possibility of incorporating additional small to mid-sized locations in the future, the Director will proactively plan, direct, and implement all aspects of the transformation program. This includes overseeing both construction safety activities and operational safety transformation program at the designated sites. The Project Director will be instrumental in fostering a strong safety culture by demonstrating exceptional leadership, communication, and engagement skills with the client and key stakeholders.JOB DESCRIPTION:Essential duties and Responsibilities:Engage client top management and resolve issues for effective implementation of safety at site.Manage the change and establish clear communication plan of the project.Communicate frequently about the project to the stakeholders (internal and external) via physical or digital communications.Reporting (Project roll out status, budget, capacity plan, Key Parameters), meeting minutes and challenges if any in regular and consistent manner.Promote best safety practices as a part of project implementation.Communicate timely to client on challenges and support required for effective project implementation.Review the program effectiveness / components and course correct, when required.Evaluate Project Managers and specialists team performance and provide feedback to Management (team size: 50 60 people).Organize platform for learning lessons and deploy learning in project.Manage construction safety and projects operational management at site.Actively engage with the client to understand their safety expectations, requirements and standards. Ensure these are integrated into the project safety management system.Collaborating with Client for safety planning, ensuring that all safety protocols are adhered to and fostering a culture of safety across the site.Foster a culture of safety consciousness among all project stakeholders, encouraging a proactive approach towards safety.Organize and lead committee meetings, and discuss safety performance, challenges and strategic decisions.

Greetings!

Position Title: Project Director ( expats only)

Client: One of the world's leading steel company

Job Location: Gujarat

Education Qualification: Minimum Bachelors in Engineering, Safety Qualification is desirable

Additional Safety Experience: Prior experience (at least 5 years) in working on Safety Culture Transformation projects

No. Of Years of Experience Required (min):

Minimum consulting exposure of 5 years, should have worked in large steel plant.

Overall Experience greater than 20 years

International Experience:

Preference for expats from the UK, Europe, Australia, middle east

Range:

45 - 55 years

Initial contract duration:

2 years, with a strong possibility of extension

Position Purpose :

The Project Director is responsible for the successful delivery of a comprehensive safety culture transformation project for a leading steel company with multiple business units across India. Initially based at the Gujarat site, with the possibility of incorporating additional small to mid-sized locations in the future, the Director will proactively plan, direct, and implement all aspects of the transformation program. This includes overseeing both construction safety activities and operational safety transformation program at the designated sites. The Project Director will be instrumental in fostering a strong safety culture by demonstrating exceptional leadership, communication, and engagement skills with the client and key stakeholders.

JOB DESCRIPTION :

Essential duties and Responsibilities:

• Engage client top management and resolve issues for effective implementation of safety at site.
• Manage the change and establish clear communication plan of the project.
• Communicate frequently about the project to the stakeholders (internal and external) via physical or digital communications.
• Reporting (Project roll out status, budget, capacity plan, Key Parameters), meeting minutes and challenges if any in regular and consistent manner.
• Promote best safety practices as a part of project implementation.
• Communicate timely to client on challenges and support required for effective project implementation.
• Review the program effectiveness / components and course correct, when required.
• Evaluate Project Managers and specialists team performance and provide feedback to Management (team size: 50 60 people).
• Organize platform for learning lessons and deploy learning in project.
• Manage construction safety and projects operational management at site.
• Actively engage with the client to understand their safety expectations, requirements and standards. Ensure these are integrated into the project safety management system.
• Collaborating with Client for safety planning, ensuring that all safety protocols are adhered to and fostering a culture of safety across the site.
• Foster a culture of safety consciousness among all project stakeholders, encouraging a proactive approach towards safety.
• Organize and lead committee meetings, and discuss safety performance, challenges and strategic decisions.

Greetings!

Position Title: Project Director ( expats only)

Client: One of the world's leading steel company

Job Location: Gujarat

Education Qualification: Minimum Bachelors in Engineering, Safety Qualification is desirable

Additional Safety Experience: Prior experience (at least 5 years) in working on Safety Culture Transformation projects

No. Of Years of Experience Required (min):

Minimum consulting exposure of 5 years, should have worked in large steel plant.

Overall Experience greater than 20 years

International Experience:

Preference for expats from the UK, Europe, Australia, middle east

Range:

45 - 55 years

Initial contract duration:

2 years, with a strong possibility of extension

Position Purpose :

The Project Director is responsible for the successful delivery of a comprehensive safety culture transformation project for a leading steel company with multiple business units across India. Initially based at the Gujarat site, with the possibility of incorporating additional small to mid-sized locations in the future, the Director will proactively plan, direct, and implement all aspects of the transformation program. This includes overseeing both construction safety activities and operational safety transformation program at the designated sites. The Project Director will be instrumental in fostering a strong safety culture by demonstrating exceptional leadership, communication, and engagement skills with the client and key stakeholders.

JOB DESCRIPTION :

Essential duties and Responsibilities:

• Engage client top management and resolve issues for effective implementation of safety at site.
• Manage the change and establish clear communication plan of the project.
• Communicate frequently about the project to the stakeholders (internal and external) via physical or digital communications.
• Reporting (Project roll out status, budget, capacity plan, Key Parameters), meeting minutes and challenges if any in regular and consistent manner.
• Promote best safety practices as a part of project implementation.
• Communicate timely to client on challenges and support required for effective project implementation.
• Review the program effectiveness / components and course correct, when required.
• Evaluate Project Managers and specialists team performance and provide feedback to Management (team size: 50 60 people).
• Organize platform for learning lessons and deploy learning in project.
• Manage construction safety and projects operational management at site.
• Actively engage with the client to understand their safety expectations, requirements and standards. Ensure these are integrated into the project safety management system.
• Collaborating with Client for safety planning, ensuring that all safety protocols are adhered to and fostering a culture of safety across the site.
• Foster a culture of safety consciousness among all project stakeholders, encouraging a proactive approach towards safety.
• Organize and lead committee meetings, and discuss safety performance, challenges and strategic decisions.

Greetings!

Position Title: Project Director ( expats only)

Client: One of the world's leading steel company

Job Location: Gujarat

Education Qualification: Minimum Bachelors in Engineering, Safety Qualification is desirable

Additional Safety Experience: Prior experience (at least 5 years) in working on Safety Culture Transformation projects

No. Of Years of Experience Required (min):

Minimum consulting exposure of 5 years, should have worked in large steel plant.

Overall Experience greater than 20 years

International Experience:

Preference for expats from the UK, Europe, Australia, middle east

Range:

45 - 55 years

Initial contract duration:

2 years, with a strong possibility of extension

Position Purpose :

The Project Director is responsible for the successful delivery of a comprehensive safety culture transformation project for a leading steel company with multiple business units across India. Initially based at the Gujarat site, with the possibility of incorporating additional small to mid-sized locations in the future, the Director will proactively plan, direct, and implement all aspects of the transformation program. This includes overseeing both construction safety activities and operational safety transformation program at the designated sites. The Project Director will be instrumental in fostering a strong safety culture by demonstrating exceptional leadership, communication, and engagement skills with the client and key stakeholders.

JOB DESCRIPTION :

Essential duties and Responsibilities:

• Engage client top management and resolve issues for effective implementation of safety at site.
• Manage the change and establish clear communication plan of the project.
• Communicate frequently about the project to the stakeholders (internal and external) via physical or digital communications.
• Reporting (Project roll out status, budget, capacity plan, Key Parameters), meeting minutes and challenges if any in regular and consistent manner.
• Promote best safety practices as a part of project implementation.
• Communicate timely to client on challenges and support required for effective project implementation.
• Review the program effectiveness / components and course correct, when required.
• Evaluate Project Managers and specialists team performance and provide feedback to Management (team size: 50 60 people).
• Organize platform for learning lessons and deploy learning in project.
• Manage construction safety and projects operational management at site.
• Actively engage with the client to understand their safety expectations, requirements and standards. Ensure these are integrated into the project safety management system.
• Collaborating with Client for safety planning, ensuring that all safety protocols are adhered to and fostering a culture of safety across the site.
• Foster a culture of safety consciousness among all project stakeholders, encouraging a proactive approach towards safety.
• Organize and lead committee meetings, and discuss safety performance, challenges and strategic decisions.