Drug Safety Specialist - Cambridge

Cambridge, United Kingdom
15 Jul 2019
14 Aug 2019
Full Time
Contract Type
Experience Level
Experienced (non-manager)
The Safety Specialist performs day-to-day adverse event reporting and subsequent Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information.

Main Responsibilities

  • Work independently to receive and manage adverse event reports and all necessary documentation resulting from inbound or outbound telephone calls and letter or facsimile transfer from a 3rd party (e.g. client). Documentation includes use of departmental Tracker, preparation of AE narratives, as directed by client format, and coding of event terms utilizing MedDRA. Assign preliminary seriousness and labeledness/listedness of event(s). Enter reported information into PPD-owned or client-provided safety database and perform necessary triage.

  • Review cases entered for quality, consistency and accuracy, including review of peer reports.

  • Independently review appropriate resources to develop and maintain knowledge of FDA regulations, Good Clinical Practices and PPD Corporate, divisional and/or client-specific policies and procedures.

  • Interact with client personnel to obtain guidance on case-specific questions, to notify of pending regulatory timelines, and maintain open lines of communication.

  • Interact with the reviewing physician(s) to discuss medical appropriateness of adverse event cases and confirm seriousness and labeledness/listedness assessments.

  • Review literature abstracts and full-text articles for reportable safety events. Identify and extract all relevant information to create an adverse event report.

  • Other duties as assigned.


Minimum Required Education and Experience:

Bachelor's degree in Nursing, Medical Technology or Pharmacy with 2+ years of clinical experience OR Life Science degree with 2+ years of clinical experience and 1 year of pharmacovigilance experience Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the job

Required Knowledge, Skills and Abilities:

General understanding of pathophysiology and the disease process

Detailed knowledge of relevant therapeutic areas as required for processing AEs

Strong critical thinking and problem solving skills

Good oral and written communication skills including paraphrasing skills

Good command of English and ability to translate information into local language where required

Computer literate with the ability to work within multiple databases

Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)Understanding the importance of and compliance with procedural documents and regulations

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

Strong attention to detail

Ability to maintain a positive and professional demeanor in challenging circumstances

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


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