Medical Writer

Job description

Location: Mohālī

This job is with Parexel, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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.

Job Description

Scheduling and coordinating meetings/ Drafting meeting agenda and minutes/Tracking action items and soliciting follow-up for open issues

Key Accountabilities :

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 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 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…