Description

RESPONSIBILITIES Responsible for management of scheduled and unscheduled aggregate reports including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), United States Periodic Adverse Drug Experience Reports (PADERs), Risk Management Plan (RMP), Health Hazard Evaluation (HHE). Independent authoring, editing and reviewing of various regulatory/clinical documents. Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions Providing input and developing literature search strategies for the epidemiology section of safety reports Ensuring that all work is complete and of high quality prior to distribution. Confirm data consistency and integrity across the document. Performs quality checks on the drafted documents as required. Assists in compilation and formatting of the documents Distributing of final reports and submission to health authorities, according to the agreed timelines, distribution lists and email templates (as required) 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 Desired Skills Expert knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, GVP Modules; respective EU Clinical Trial Directive etc.) Good knowledge of regulatory documentation, drug development process and global regulations and guidelines. Previous experience of pharmacovigilance medical writing, including PBRERs/PSURs, and RMPs Ability to manage multiple and varied tasks and prioritize workload. Attention to detail and decision-making skills. Ability to effectively train and mentor Associate/Junior Medical Writers Knowledge of document management systems and other relevant applications (e.g. Excel, Outlook). Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting Role: Medical Writer Industry Type: Pharmaceutical & Life Sciences Department: Research & Development Employment Type: Full Time, Permanent Role Category: Pharmaceutical & Biotechnology

Role and Responsibilities

• RESPONSIBILITIES Responsible for management of scheduled and unscheduled aggregate reports including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), United States Periodic Adverse Drug Experience Reports (PADERs), Risk Management Plan (RMP), Health Hazard Evaluation (HHE). Independent authoring, editing and reviewing of various regulatory/clinical documents. Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions Providing input and developing literature search strategies for the epidemiology section of safety reports Ensuring that all work is complete and of high quality prior to distribution. Confirm data consistency and integrity across the document. Performs quality checks on the drafted documents as required. Assists in compilation and formatting of the documents Distributing of final reports and submission to health authorities, according to the agreed timelines, distribution lists and email templates (as required) 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 Desired Skills Expert knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, GVP Modules; respective EU Clinical Trial Directive etc.) Good knowledge of regulatory documentation, drug development process and global regulations and guidelines. Previous experience of pharmacovigilance medical writing, including PBRERs/PSURs, and RMPs Ability to manage multiple and varied tasks and prioritize workload. Attention to detail and decision-making skills. Ability to effectively train and mentor Associate/Junior Medical Writers Knowledge of document management systems and other relevant applications (e.g. Excel, Outlook). Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting Role: Medical Writer Industry Type: Pharmaceutical & Life Sciences Department: Research & Development Employment Type: Full Time, Permanent Role Category: Pharmaceutical & Biotechnology