Pharmacovigilance Medical Writer (PSURs, Summary Bridging Reports, etc.)

The consultant will be responsible for data gathering and the production of aggregate reports (including PSURs, Summary Bridging Reports, Commented Line Listings and others) for assigned products including planning, writing, addressing reviewer comments, and assembly of final document. Contractor will also perform peer reviews of written reports and publications for other PVAR group members.

Reporting:
This person will report to Manager or Associate Director, Pharmacovigilance Aggregate Reporting


Educational background/experience:

-Candidate should have a degree in health or biomedical science.
-Industry writing experience and drug safety experience highly preferred, as well as project management experience.
-Person should be a strong independent worker but also be a valuable contributor in a team/matrix setting. -Should have strong Microsoft Word and Excel ability.
-Excellent verbal and written communication skills.