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- Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Risk Management Plan (RMP), Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs) as well as preparing document of comparison between local and global labeling document (if applicable) and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and signal detection and management (where applicable).
- Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions, tests electronic submissions gateways, and tracking compliance monitoring of submissions in accordance with client/international conventions
- Responsible for preparing the narratives associated with the client’s/sponsor’s products from clinical trials for Clinical Study Reports (CSRs) or in order to support any health authority requests in accordance with regulatory and client’s/sponsor’s requirements
- Scheduling and Attending meetings/ Drafting meeting agenda and minutes/Tracking action items.
Key Accountabilities:
Note: The below statements describe the general nature and level of the work being performed and are not an exhaustive list of all responsibilities required for the position. Responsibilities vary as applicable
Accountability
Supporting Activities
Aggregate reports
- Preparing/updating/merging RMPs/Company Core-RMPs (CC-RMPs), preparing a health authority response document along with RMS update in accordance with client requirements/conventions and SOPs.
- Managing scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs), comparison document between local and global labeling document (if applicable)and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and conventions and SOPs
- Conducting critical appraisal and systematic review of literature with a focus on background epidemiology, specifically information on the incidence, prevalence and risk factor in patient populations, for inclusion in drug Safety Reports and RMPs
- Providing input and developing literature search strategies for the epidemiology section of safety reports
- Applying epidemiological methods and calculations to data available in literature to support the background rates of the issues under evaluation for the safety reports
- Generating Line Listings for submissions/ to identifying discrepancies and ensuring resolution of the discrepancies
- Revising document drafts based on the review comments from team members to ensure inclusion of all relevant input.
- Ensuring that all work is complete and of high quality prior to team or client distribution. Confirm data consistency and integrity across the document.
- Performing aggregate report compliance activities including quality review to check the data/facts and internal consistency across various type of aggregate reports including but not limited to PBRERs, Ad hocs, HHEs, LJDs, tables, RMP, Pharmacovigilance System Master File (PSMF) document (as applicable)
- Distributing of final reports to the stakeholders including partners, affiliates and submission to health authorities, according to the agreed timelines, distribution lists and email templates (as required)
- Scheduling and Attending meetings/ Drafting meeting agenda and minutes/Tracking action items
Clinical Study Report Narratives
- Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client and ensures their appropriate medical cohesiveness and assessment in accordance with the client’s and Parexel’s conventions/guidelines and Standard Operating Procedures
- Ensure that all work is accurate, complete and of high quality.
- Performs quality checks on the drafted narratives as required
- Assists in compilation and formatting of the narrative deliverables
Signal Detection and Management
- Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc.
- Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the safety science
- Conduct/support signal detection and evaluation activities according to SOPs and guidelines
General
- Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations
- Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting
- Maintaining a good working knowledge of the assigned Clinical studies for narratives
- Ensuring that all work is complete and of high-quality
- Attending internal, drug safety and project specific training sessions
- Preparation for, participation in, and follow up on audits and inspections
- Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
- Delegating work as appropriate to Associate Medical Writer
- Striving to enhance client’s satisfaction based on feedback provided by the client
- Serving as the primary client contact, liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
- Evaluating and incorporating reviewer comments in draft reports and liaising with relevant contributors for resolution of comments
- Mentoring new recruits in the team, if required
- Archiving the source documents and relevant emails as required
- Responding to clients/customers in a timely manner
Skills:
- Analytical and problem-solving skills
- Excellent interpersonal skills
- Excellent organizational and prioritization skills
- Ability to work collaboratively and effectively in a team environment
- Client focused approach to work
- Ability to evaluate data and draw conclusions independently
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Ability to understand all necessary steps in a project, plan steps ahead, and identify critical paths.
- Fluency in written and spoken English
- Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
- Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
- Typing and transcription accuracy
- Awareness of global culture and willingness to work in a matrix environment.
Knowledge and Experience:
- Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field.
- Good knowledge of medical terminologies
Education:
- Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)
- A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage
Job Purpose:
- Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Risk Management Plan (RMP), Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs) as well as preparing document of comparison between local and global labeling document (if applicable) and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and signal detection and management (where applicable).
- Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions, tests electronic submissions gateways, and tracking compliance monitoring of submissions in accordance with client/international conventions
- Responsible for preparing the narratives associated with the client’s/sponsor’s products from clinical trials for Clinical Study Reports (CSRs) or in order to support any health authority requests in accordance with regulatory and client’s/sponsor’s requirements
- Scheduling and Attending meetings/ Drafting meeting agenda and minutes/Tracking action items.
Key Accountabilities:
Note: The below statements describe the general nature and level of the work being performed and are not an exhaustive list of all responsibilities required for the position. Responsibilities vary as applicable
Accountability
Supporting Activities
Aggregate reports
- Preparing/updating/merging RMPs/Company Core-RMPs (CC-RMPs), preparing a health authority response document along with RMS update in accordance with client requirements/conventions and SOPs.
- Managing scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs), comparison document between local and global labeling document (if applicable)and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and conventions and SOPs
- Conducting critical appraisal and systematic review of literature with a focus on background epidemiology, specifically information on the incidence, prevalence and risk factor in patient populations, for inclusion in drug Safety Reports and RMPs
- Providing input and developing literature search strategies for the epidemiology section of safety reports
- Applying epidemiological methods and calculations to data available in literature to support the background rates of the issues under evaluation for the safety reports
- Generating Line Listings for submissions/ to identifying discrepancies and ensuring resolution of the discrepancies
- Revising document drafts based on the review comments from team members to ensure inclusion of all relevant input.
- Ensuring that all work is complete and of high quality prior to team or client distribution. Confirm data consistency and integrity across the document.
- Performing aggregate report compliance activities including quality review to check the data/facts and internal consistency across various type of aggregate reports including but not limited to PBRERs, Ad hocs, HHEs, LJDs, tables, RMP, Pharmacovigilance System Master File (PSMF) document (as applicable)
- Distributing of final reports to the stakeholders including partners, affiliates and submission to health authorities, according to the agreed timelines, distribution lists and email templates (as required)
- Scheduling and Attending meetings/ Drafting meeting agenda and minutes/Tracking action items
Clinical Study Report Narratives
- Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client and ensures their appropriate medical cohesiveness and assessment in accordance with the client’s and Parexel’s conventions/guidelines and Standard Operating Procedures
- Ensure that all work is accurate, complete and of high quality.
- Performs quality checks on the drafted narratives as required
- Assists in compilation and formatting of the narrative deliverables
Signal Detection and Management
- Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc.
- Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the safety science
- Conduct/support signal detection and evaluation activities according to SOPs and guidelines
General
- Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations
- Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting
- Maintaining a good working knowledge of the assigned Clinical studies for narratives
- Ensuring that all work is complete and of high-quality
- Attending internal, drug safety and project specific training sessions
- Preparation for, participation in, and follow up on audits and inspections
- Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
- Delegating work as appropriate to Associate Medical Writer
- Striving to enhance client’s satisfaction based on feedback provided by the client
- Serving as the primary client contact, liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
- Evaluating and incorporating reviewer comments in draft reports and liaising with relevant contributors for resolution of comments
- Mentoring new recruits in the team, if required
- Archiving the source documents and relevant emails as required
- Responding to clients/customers in a timely manner
Skills:
- Analytical and problem-solving skills
- Excellent interpersonal skills
- Excellent verbal / written communication skills
- Excellent organizational and prioritization skills
- Ability to work collaboratively and effectively in a team environment
- Client focused approach to work
- Ability to evaluate data and draw conclusions independently
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Ability to understand all necessary steps in a project, plan steps ahead, and identify critical paths.
- Fluency in written and spoken English
- Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
- Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
- Typing and transcription accuracy
- Awareness of global culture and willingness to work in a matrix environment.
Knowledge and Experience:
- Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field.
- Good knowledge of medical terminologies
Education:
- Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)
- A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage
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Originaly published: Aug. 2, 2024, 4:32 p.m.
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