Safety Writer

Job Description

SummarizedPurpose:

Responsible for the planningcoordination and delivery of safety writing services for multipleclinical trial and/or marketed product projects. Performs daytodaysafety writing and related activities within a highly regulatedpharmacovigilance environment driven by strict timelines.Activities include but are not limited to delivery of lowcomplexity safety writing deliverables through achievement of thefollowing tasks: project management data review authoring andquality review. May also support authoring of medium complexitydeliverables. Effectively collaborates with various partiesincluding but not limited to: PVG project team members widerPPD/Evidera project team members client contacts and third partyvendors.

Essential Functions

Conducts data review authoring and quality review tasks on andproject

manages a range of low complexityclinical trial and marketed productsafety

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

May additionally support authoring ofmedium complexity deliverables (e.g.

DevelopmentSafety Update Reports (DSURs) Periodic Safety UpdateReports

(PSURs)/Periodic Benefit Risk EvaluationReports (PBRERs) development Risk Management Plans (dRMPs)) undersupervision from more senior staff.

Usesmultiple company and client systems. Interacts with project teammembers and clients.

Operates in a lead capacityserving as the primary point of contact for assigned low complexitysafety writing deliverables.

Ensures thatassigned safety writing tasks are conducted in accordance withcompany policies and procedures contractual agreements andapplicable regulations.

Reviewsregulatory/pharmacovigilance publications and information sourcesto keep updated on current regulations practices andprocedures.

Performs routine projectimplementation and coordination of activitiesfor

assigned safety writing projects includingmanaging communications and data requests and participating inkickoff meetings client meetings audits andinspections.

Education andExperience:

Bachelors degree or equivalent andrelevant formal academic / vocational qualification Previousexperience that provides the knowledge skills and abilities toperform the job (comparable to 2 years).

In somecases an equivalency consisting of a combination of appropriateeducation training and/or directly related experience will beconsidered sufficient for an individual to meet the requirements ofthe role.

Knowledge Skills andAbilities:

Good knowledge of ICH and USaggregate safety reporting formats relating to clinical trialsand/or marketed products

Good attention todetail; good data interpretation and medicalscientific writingskills

Solid critical thinking and problemsolving skills with ability to escalateappropriately

Ability to manage and prioritize avariety of tasks and meet strict deadlines with modestsupervision

Effective oral and written Englishlanguage communication skills including paraphrasingskills

Good computer skills with the ability towork within multiple systems; proficient in use of Microsoft Officeproducts (including Outlook Word and Excel)

Goodunderstanding of the global regulatory requirements pertaining topharmacovigilance and the importance of and compliance withprocedural documents and regulations

Ability tomaintain a positive and professional demeanor in challengingcircumstances

Ability to work effectively withina team to attain a shared goal

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RemoteWork :

No