Associate Dir/Dir Pharmacovigilance & Risk Mgt. Writing

Successful PA-based pharmaceutical company has an exciting, newly created position for a Assistant Director or Director level medical  report writer with experience writing Pharmacovigilance & Risk Management documents. Excellent salary, bonus, benefits.Good Growth potential. Relocation assistance offered.  Seeking a hands-on PV writer for this role. 

Responsibilities include:  Medical writing, management of reference documentation, training and quality control associated with aggregate report writing in pharmacovigilance. Activities include the preparation and expert oversight in of company Periodic Safety Update Reports, Risk Management Plans, responses to regulatory inquiries and ad hoc safety reports.

Requirements:  Life Science Degree or healthcare professional. Post-graduate qualification (PhD, PharmD) in a relevant discipline preferred. Minimum of 5 years previous experience working in a similar role with direct experience of aggregate report preparation (PSURs, ASRs, Integrated Summaries of Safety, etc). Ability to summarize aggregate safety data and identify the key areas for focus in reports. Excellent interpersonal & mentoring skills Experience with SOP development Solid understanding of the regulations supporting aggregate regulatory reports including ICH guidance, FDA regulations, the E.U. Clinical Trial Directive and Volume 9a. Self-starter

Please send resume in a word format attachment to execquest@comcast.net or call Lisa FitzGerald for more information @ 877-467-4099