Use your scientific and Pharmacovigilance expertise to join the
world?s leading comprehensive pharmaceutical safety services
organization on a fast-growing team performing Regulatory Reporting
submissions. Apply your expertise, including GVP and/or GCP knowledge,
complex decision making and working towards strict deadlines to meet
legislative timelines.
Be a part of a global team to help ensure the safety profile of a
COVID-**Apply on the website** vaccine with opportunities to improve
worldwide public health.
ROLES AND RESPONSIBILITIES:
* Review, assess and perform quality control on expedited and
periodic Lifecycle Safety data from both clinical trials and post
marketing studies.
* Expedited reports are received from multiple sources including,
but not limited to, solicited clinical trial reports, post marketing
surveillance reports, spontaneous reports, literature reports and
legal reports for drugs, devices, consumer healthcare, cosmetic and
dietary products.
* Periodic reports include, but are not limited to, Development
Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Report
(PBRER) and Line Listings.
* Triage safety data to identify the seriousness, relatedness and
expectedness of events and determine reportability of cases based on
the combination of this information.
* Distribute data to Regulatory Authorities, Ethics Committees,
investigator sites, customers, licensing partners (LPs) and marketing
authorisation holders (MAHs) as appropriate based on approvals of
clinical trials and authorisations for drugs to be placed on the
markets in different territories.
* Adhere to International Conference on Harmonisation ? Good
Clinical Practice (ICH-GCP), Good Pharmacovigilance Practice (GVP)
modules and country legislation to ensure submission of safety
information is made by the required timelines and by the correct
transmission method.
* Database all submissions and use information in databases to
calculate metrics and generate status and compliance report on a
monthly basis, or as required.
* Perform User Acceptance Testing (UAT) on new databases and assist
in configuring databases with project specific information.
* Create and maintain project specific submission templates.
* Liaise with internal and external functional teams transnationally
to facilitate submissions of both expedited and periodic reports.
* Review project files at defined time-points to ensure audit and
inspection readiness.
* Identify non-efficient processing methods, highlight and document
process improvements.
* Participate in pilot and time-in-motion studies to implement
process changes.
* Mentor junior team members.
* Develop and roll-out project or process trainings as areas of
expertise develop.
* Document quality issues on projects, identify and implement
corrective actions and preventative actions where necessary.
* Contribute and help drive global initiatives such as process
automation, quality, training and databasing legislation.
* Perform all tasks in accordance to GCP, GVP modules, Standard
Operating Procedures (SOPs) and project specific requirements.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
* Working knowledge of Lifecycle Safety services. Familiarity with
functionality of IQVIA Regulatory Database and Endpoint Tracking
Database.
* Basic knowledge of applicable global, regional, local clinical
research regulatory requirements; i.e. Good Clinical Practice (GCP)
and International Conference of Harmonization (ICH) guidelines, SOPs.
* Ability to meet strict deadlines; manage competing priorities and
changing demands.
* Sound organization and time management skills.
* Ability to follow instructions/guidelines, work independently and
on own initiative.
* Good attention to detail and accuracy and maintain high quality
standards.
* Demonstrate good IT skills.
* Effective written and verbal communication skills.
* Ability to be flexible and receptive to changing process demands.
* Willingness and aptitude to learn new skills across Lifecycle
Safety service lines.
* Ability to establish and maintain effective working relationships
with co-workers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
* Bachelor?s Degree in scientific or healthcare discipline
* 2+ years experience in Pharmacovigilance / **Apply on the
website** years laboratory experience
* Must be Fluent in English
REGULATORY REPORTING ? OPERATIONS SPECIALIST 2
Use your scientific and Pharmacovigilance expertise to join the
world?s leading comprehensive pharmaceutical safety services
organization on a fast-growing team performing Regulatory Reporting
submissions. Apply your expertise, including GVP and/or GCP knowledge,
complex decision making and working towards strict deadlines to meet
legislative timelines.
Be a part of a global team to help ensure the safety profile of a
COVID-**Apply on the website** vaccine with opportunities to improve
worldwide public health.
ROLES AND RESPONSIBILITIES:
* Review, assess and perform quality control on expedited and
periodic Lifecycle Safety data from both clinical trials and post
marketing studies.
* Expedited reports are received from multiple sources including,
but not limited to, solicited clinical trial reports, post marketing
surveillance reports, spontaneous reports, literature reports and
legal reports for drugs, devices, consumer healthcare, cosmetic and
dietary products.
* Periodic reports include, but are not limited to, Development
Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Report
(PBRER) and Line Listings.
* Triage safety data to identify the seriousness, relatedness and
expectedness of events and determine reportability of cases based on
the combination of this information.
* Distribute data to Regulatory Authorities, Ethics Committees,
investigator sites, customers, licensing partners (LPs) and marketing
authorisation holders (MAHs) as appropriate based on approvals of
clinical trials and authorisations for drugs to be placed on the
markets in different territories.
* Adhere to International Conference on Harmonisation ? Good
Clinical Practice (ICH-GCP), Good Pharmacovigilance Practice (GVP)
modules and country legislation to ensure submission of safety
information is made by the required timelines and by the correct
transmission method.
* Database all submissions and use information in databases to
calculate metrics and generate status and compliance report on a
monthly basis, or as required.
* Perform User Acceptance Testing (UAT) on new databases and assist
in configuring databases with project specific information.
* Create and maintain project specific submission templates.
* Liaise with internal and external functional teams transnationally
to facilitate submissions of both expedited and periodic reports.
* Review project files at defined time-points to ensure audit and
inspection readiness.
* Identify non-efficient processing methods, highlight and document
process improvements.
* Participate in pilot and time-in-motion studies to implement
process changes.
* Mentor junior team members.
* Develop and roll-out project or process trainings as areas of
expertise develop.
* Document quality issues on projects, identify and implement
corrective actions and preventative actions where necessary.
* Contribute and help drive global initiatives such as process
automation, quality, training and databasing legislation.
* Perform all tasks in accordance to GCP, GVP modules, Standard
Operating Procedures (SOPs) and project specific requirements.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
* Working knowledge of Lifecycle Safety services. Familiarity with
functionality of IQVIA Regulatory Database and Endpoint Tracking
Database.
* Basic knowledge of applicable global, regional, local clinical
research regulatory requirements; i.e. Good Clinical Practice (GCP)
and International Conference of Harmonization (ICH) guidelines, SOPs.
* Ability to meet strict deadlines; manage competing priorities and
changing demands.
* Sound organization and time management skills.
* Ability to follow instructions/guidelines, work independently and
on own initiative.
* Good attention to detail and accuracy and maintain high quality
standards.
* Demonstrate good IT skills.
* Effective written and verbal communication skills.
* Ability to be flexible and receptive to changing process demands.
* Willingness and aptitude to learn new skills across Lifecycle
Safety service lines.
* Ability to establish and maintain effective working relationships
with co-workers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
* Bachelor?s Degree in scientific or healthcare discipline
* 2+ years experience in Pharmacovigilance / **Apply on the
website** years laboratory experience
* Must be Fluent in English
We need : English (Good)
Type: Permanent
Payment:
Category: Others
