Safety Writer

Job Description

Summarized Purpose:

Responsible for the planning coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs daytoday safety writing and related activities within a highly regulated pharmacovigilance environment driven by strict timelines. Activities include but are not limited to delivery of low complexity safety writing deliverables through achievement of the following tasks: project management data review authoring and quality review. May also support authoring of medium complexity deliverables. Effectively collaborates with various parties including but not limited to: PVG project team members wider PPD/Evidera project team members client contacts and third party vendors.

Essential Functions

Conducts data review authoring and quality review tasks on and project

manages a range of low complexity clinical trial and marketed product safety

writing deliverables (e.g. line listing reports; Periodic Adverse Drug Experience Reports (PADERs)).

May additionally support authoring of medium complexity deliverables (e.g.

Development Safety Update Reports (DSURs) Periodic Safety Update Reports

(PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) development Risk Management Plans (dRMPs)) under supervision from more senior staff.

Uses multiple company and client systems. Interacts with project team members and clients.

Operates in a lead capacity serving as the primary point of contact for assigned low complexity safety writing deliverables.

Ensures that assigned safety writing 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.

Performs routine project implementation and coordination of activities for

assigned safety writing projects including managing communications and data requests and participating in kickoff meetings client meetings audits and inspections.

Education and Experience:

Bachelors degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2 years).

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities:

Good knowledge of ICH and US aggregate safety reporting formats relating to clinical trials and/or marketed products

Good attention to detail; good data interpretation and medicalscientific writing skills

Solid critical thinking and problem solving skills with ability to escalate appropriately

Ability to manage and prioritize a variety of tasks and meet strict deadlines with modest supervision

Effective oral and written English language communication skills including paraphrasing skills

Good computer skills with the ability to work within multiple systems; proficient in use of Microsoft Office products (including Outlook Word and Excel)

Good understanding of the global regulatory requirements pertaining to pharmacovigilance and the importance of and compliance with procedural documents and regulations

Ability to maintain a positive and professional demeanor in challenging circumstances

Ability to work effectively within a team to attain a shared goal

Please use the below link for job application and quicker response.

Remote Work :

No