Medical Writer

We are working with a global Pharmaceutical company who are looking for a Medical Writer to join their team on a 6 months contract which starts at the beginning of November. The ideal candidate must have extensive experience of writing PSURS/Aggregate Reports.

PRINCIPAL RESPONSIBILITIES:

Ensure timely, quality aggregate reports for assigned products.

* Support PVAR Scientists in the creation/format of Aggregate reports, including Periodic Safety Update Reports (PSURs) and Summary Bridging Reports.

* Data quality review/correction.

Ability to reprioritize work based on shifting business needs to meet report timelines.Ability to interact with staff at various levels and in various functional areas to address issues found during review and drive timely solutions.Take personal accountability for decisions and delivering results.Evaluate comments from reviewers of draft reports for appropriateness and respond accordingly.Constantly (re)prioritize work to manage projects often requiring multitasking skills.Data cleaning/QC skills.

Required Skills/Abilities:

Quality orientation/attention to detail.
Ability to work independently and as part of a team.
Accountability and responsibility for delivery of results.
Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines.
Ability to follow standard operating proceduresExcellent verbal and written communication skills (oral, formal, e-mail and teleconference); ability to communicate in a global environment: diplomatic.
Microsoft Word competence (tables, basic formatting).
Documentum systems familiarity.
Global Safety-Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to pharmacovigilance).
Windows OS familiarity/maneuverability.
MS Excel skills.
Web-based program/Internet competence.

This is a Maternity Cover within PVAR. The successful candidate will be required to write reports to health authorities, have prior experience in PSUR writing, to have experience in Drug Safety/PVG, to be able to work to deadlines, have great attention to detail, and strong word/excel skills.