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- Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs), 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.
- Imparting trainings to the new starts during the induction sessions and the team as required.
- Demonstrating document leadership: communicating content requirements, coordinating and conducting interdepartmental team review of draft and final documents, scheduling and leading/facilitating authoring team meetings to agree on expectations, evaluate progress on tasks, identifying issues and facilitating resolutions, managing/driving the timeline, and advance document development to approval.
- Striving to enhance client’s satisfaction based on feedback provided by the client.
- Helping in management of process related queries at user level.
- Acting in the capacity of lead, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues.
- Project management of contractual and financial aspects, as necessary with guidance from management.
- Identifying areas of concern within the team and raising the issues with project manager.
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 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, 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), 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.
- 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).
- Generating Line Listings for submissions to identifying discrepancies and ensuring resolution of the discrepancies.
- Distribution 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 coordinating meetings/ Drafting meeting agenda and minutes/Tracking action items and soliciting follow-up for open issues.
Clinical Study Report Narratives
- Coordinates and liaises with the members of Study Management Team (SMT)/Study In-charge or equivalent, to discuss the narrative template development process, narrative categories and review of the narratives (as required).
- Serves as primary client contact for narrative writing for an assigned study, agreeing/negotiating deliverable timelines, and addressing/resolving any narratives related issues (as required).
- 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.
- Performs quality checks on the drafted narratives as required.
- Ensures the work is complete and of high quality, including final quality control checks, compilation and formatting.
- Provides CSR narrative review support to the SMT where requested.
- Build and maintain collaborative relationships with SMTs for an efficient, productive, and professional working relationship (as applicable).
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 GSO.
- 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.
- Attending/conducting internal, drug safety and project specific training sessions.
- 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.
- 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).
- Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services.
- Provides departmental expertise and perspectives to promote prospective business opportunities.
- 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.
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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