59 Safety Advisor jobs in India
Safety Advisor
Posted today
Job Viewed
Job Description
As the Safety Advisor, you'll oversee WHS on a complex multi-storey build involving basement works, vertical structure, and high-rise. You'll work closely with the Project Manager, Site Managers, Engineers, and subcontractors to embed safety across all phases of construction.
Key Responsibilities
- Lead site safety across excavation, basement, structural and finishing stages of a multi-storey development.
- Conduct site inspections, audits, and high-risk activity reviews (crane lifts, working at heights, confined spaces).
- Deliver safety inductions, toolbox talks, and ongoing training tailored for high-rise environments.
- Oversee SWMS, risk registers, incident investigations, and ensure corrective actions are implemented.
- Drive emergency preparedness and coordinate drills specific to multi-level works.
- Foster a zero-harm culture while ensuring compliance with QLD WHS legislation and company systems.
- Certificate IV in WHS.
- 3-5+ years' safety experience on multi-storey commercial or residential projects.
- Strong understanding of QLD WHS legislation, Codes of Practice, and Australian Standards.
- Confident communicator who can engage site teams and subcontractors.
- Skilled in safety/project software (HammerTech, Procore, SignOnSite, or similar). Current First Aid/CPR certification.
- Play a key role on a high-profile multi-storey build in Brisbane.
- Join a national contractor with a strong pipeline of high-rise projects.
- Competitive salary and clear career growth opportunities.
About Brunel:
Brunel is a recruitment and flexible workforce solution provider which connects talented people with opportunities throughout Australasia and around the world. We specialise in highly skilled roles across a variety of technical, professional, trades and craft disciplines, pairing candidates with industry-leading projects and organisations on a contract, permanent or secondment basis.
Operating in Australasia since 1997, Brunel has major bases of operation in Perth, Sydney, Brisbane, Melbourne and Port Moresby, which are further backed by the strength and reach of a truly global network spanning over 45 countries, 120 offices and 50 years of successful operation.
Brunel is proud to be equal opportunity employer and encourages applications from Aboriginal and Torres Strait Islander and female candidates.
Do you have questions?
If you have any questions or would like to discuss the details of this role, please contact Ryan on or at for a confidential chat.
Senior Medical safety advisor
Posted 7 days ago
Job Viewed
Job Description
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.
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, ed
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 is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Senior Medical safety advisor
Posted 7 days ago
Job Viewed
Job Description
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.
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, ed
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 is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Sr. Medical Safety Advisor
Posted 8 days ago
Job Viewed
Job Description
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.
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
- Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
- Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable
- Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product's safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)
- Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective
- Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment.
- Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team
- Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives
- Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable
- Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable
- Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable
- Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable
- 24 hour medical support as required on assigned projects
- Maintain awareness of medical safety-regulatory industry developments
- Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable
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) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req
- Two (2) years of pharma experience Pref
- Sound knowledge of Medicine
- In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Knowledge of Pharmacovigilance- ICSR and Aggregate reports
- In-depth knowledge of departmental standard operating procedures (SOPs)
- Skill in use of multiple safety databases
- Adequate Computer skills, especially Microsoft word, excel & PowerPoint
- Good communication skills- verbal and written
- Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives
- 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 is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Sr Medical Safety Advisor

Posted 23 days ago
Job Viewed
Job Description
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.
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
- Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
- Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable
- Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product's safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)
- Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective
- Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment.
- Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team
- Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives
- Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable
- Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable
- Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable
- Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable
- 24 hour medical support as required on assigned projects
- Maintain awareness of medical safety-regulatory industry developments
- Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable
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) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req
- Two (2) years of pharma experience Pref
- Sound knowledge of Medicine
- In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Knowledge of Pharmacovigilance- ICSR and Aggregate reports
- In-depth knowledge of departmental standard operating procedures (SOPs)
- Skill in use of multiple safety databases
- Adequate Computer skills, especially Microsoft word, excel & PowerPoint
- Good communication skills- verbal and written
- Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives
- 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 is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Sr Medical Safety Advisor

Posted 23 days ago
Job Viewed
Job Description
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.
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
- Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
- Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable
- Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product's safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)
- Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective
- Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment.
- Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team
- Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives
- Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable
- Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable
- Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable
- Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable
- 24 hour medical support as required on assigned projects
- Maintain awareness of medical safety-regulatory industry developments
- Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable
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) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req
- Two (2) years of pharma experience Pref
- Sound knowledge of Medicine
- In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Knowledge of Pharmacovigilance- ICSR and Aggregate reports
- In-depth knowledge of departmental standard operating procedures (SOPs)
- Skill in use of multiple safety databases
- Adequate Computer skills, especially Microsoft word, excel & PowerPoint
- Good communication skills- verbal and written
- Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives
- 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 is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Health and Safety Advisor
Posted today
Job Viewed
Job Description
Health and Safety Advisor
The Opportunity
We’re looking for a proactive and passionate Health & Safety Advisor to join our team on the Auckland Harbour Bridge. You’ll play a crucial role in keeping our people safe while contributing to the ongoing maintenance of an iconic piece of New Zealand infrastructure.
For the right person, this role offers genuine career progression and the opportunity to sharpen your skills in a unique and challenging environment.
What You’ll Do
- Build strong relationships across the project while promoting SRG Global’s safety-first culture.
- Support operational teams with training, hazard identification, incident reporting, and analysis.
- Maintain and review risk registers, and guide team-based risk assessments.
- Lead and support end-to-end safety investigations, providing practical solutions.
- Share safety updates through toolbox talks, committee meetings, and other channels.
- Conduct routine site inspections and help address safety concerns proactively.
- Facilitate internal training programs and stay current with industry regulations.
What We’re Looking For
- 5+ years’ experience in a Health & Safety role, ideally in an industrial or critical infrastructure maintenance setting.
- A relevant H&S qualification and proven experience in leading investigations.
- Strong people skills with the ability to influence and engage at all levels.
- Hands-on approach, comfortable working at heights and on-site.
- Confident with systems, reporting, and safety investigations.
Benefits and Perks:
- Competitive salary package commensurate with experience.
- Medical & Life Insurance
- Professional development opportunities to enhance your skills and knowledge.
- A collaborative and inclusive work environment.
About SRG Global
SRG Global is a diversified industrial services company. We bring an engineering mindset to deliver critical services for major industry through our asset maintenance, mining services, engineering, and construction businesses to solve complex problems across the entire asset lifecycle.
We Offer:
If you have experience in this area and are willing to contribute as part of a high-performance team, this is a perfect role for you. SRG Global fully support and promote organic growth within our organisation. This is an opportunity to gain further experience and career progression.
Apply Now:
If you would like to join our team please click the “apply” button now.
No Agency contact please – We do not accept unsolicited Agency CV’s.
*By submitting your personal information to SRG Global you consent to such information being collected, held, used and disclosed in accordance with the Privacy act 2020.
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Sr. Medical Safety Advisor
Posted today
Job Viewed
Job Description
Job Overview
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.
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
• Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable
• Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product’s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)
• Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective
• Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment.
• Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team
• Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives
• Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable
• Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable
• Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable
• Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable
• 24 hour medical support as required on assigned projects
• Maintain awareness of medical safety-regulatory industry developments
• Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable
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) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req
• Two (2) years of pharma experience Pref
• Sound knowledge of Medicine
• In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Knowledge of Pharmacovigilance- ICSR and Aggregate reports
• In-depth knowledge of departmental standard operating procedures (SOPs)
• Skill in use of multiple safety databases
• Adequate Computer skills, especially Microsoft word, excel & PowerPoint
• Good communication skills- verbal and written
• Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives
• 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
Senior Medical safety advisor
Posted today
Job Viewed
Job Description
Job Overview
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.
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, ed
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
Sr Medical Safety Advisor
Posted today
Job Viewed
Job Description
Job Overview
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.
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
• Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable
• Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product’s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)
• Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective
• Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment.
• Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team
• Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives
• Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable
• Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable
• Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable
• Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable
• 24 hour medical support as required on assigned projects
• Maintain awareness of medical safety-regulatory industry developments
• Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable
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) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req
• Two (2) years of pharma experience Pref
• Sound knowledge of Medicine
• In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Knowledge of Pharmacovigilance- ICSR and Aggregate reports
• In-depth knowledge of departmental standard operating procedures (SOPs)
• Skill in use of multiple safety databases
• Adequate Computer skills, especially Microsoft word, excel & PowerPoint
• Good communication skills- verbal and written
• Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives
• 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