Safety Writer III

Job Title: Safety Writer III

Job Location: Remote, India

Job Location Type: Remote

Job Contract Type: Full time
Job Seniority Level:

Environmental Conditions: Office

Work Schedule: Standard (Mon-Fri)
Work Schedule
Standard (Mon-Fri) Environmental Conditions
Office Job Description
Job Description

Join Us as a Safety Writer III– Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As a Safety Writer III, you will be responsible for the planning, coordination, and delivery of safety writing services for clinical trial and/or marketed product projects, including where the company serves as a pharmacovigilance functional service provider to the client in question. You will perform day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Your activities will include, but are not limited to, the delivery of safety writing deliverables ranging from low to high complexity through tasks such as project management, data review, authoring, quality review, and senior review. You may additionally provide support for scientific safety services on an ad-hoc basis. You will effectively collaborate with various parties, including but not limited to, PVG project team members, wider PPD/Evidera project team members, client contacts, and third-party vendors.

What You’ll Do:

• Conducts data review, authoring, quality review, and senior review tasks on, and project manages a wide range of clinical trial and marketed product safety writing deliverables. These include low complexity (e.g. line listing reports; Periodic Adverse [Drug] Experience Reports (PA[D]ERs)), moderate complexity (e.g. Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), development Risk Management Plans (dRMPs)) and high complexity (Risk Management Plans (RMPs), marketing authorization dossier content, customized safety writing deliverables and regulatory authority assessment report responses) deliverables.
• May additionally provide support for scientific safety services on an ad-hoc basis.
• Uses multiple PPD and client systems. Interacts with PPD/Evidera project team members and clients.
• Functions in a lead role, serving as the primary point of contact for assigned safety writing deliverables. Exercises independent judgment to troubleshoot and resolve project issues and to identify areas for improvement. Mentors less experienced staff.
• Ensures that assigned safety writing and project management tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices and procedures.
• Participates in departmental initiatives; Serves as a subject matter expert in designated area.
• Performs routine project implementation and coordination activities for assigned safety writing projects (including functional service provider clients), including leading kick-off meetings, managing communications and data requests, participating in client meetings, audits and inspections, and reviewing of metrics and budgets.

Education and Experience Requirements:

• Bachelor's or higher scientific degree.
• Must have a minimum of 6 years' experience in authoring and quality control review of all of the following report/document types for innovative medicinal products:

- DSURs

- PBRERs/PSURs

- PA(D)ERs

- RMPs

Knowledge, Skills and Abilities:

• Highly Skilled in ICH and US aggregate safety reporting formats relating to both clinical trials an