Senior or Lead Medical Writer (Safety)
- Experience Level
- Experienced (non-manager)
Senior / Lead Medical Writer (Safety) opportunity working on post-marketing aggregate safety and risk management document writing. This is a client dedicated position with Covance by Labcorp, working for a global Pharmaceutical client.
We require an experiencedSenior or Lead Safety Medical writer (depending on experience level) with post-marketing aggregate and safety medical writing experience.
Flexible locations can be consideredwithin EMEA /European regions. Homebased and office based options.
Developing strategy, planning, managing, authoring, implementing comments and sharing the drafts of PSUR R2, PSUR R1, DSUR, DHCP communication, ACOs, other regional ARs, and ad-hoc reports with the client.
- Developing strategy, planning, managing, authoring, implementing comments and sharing the drafts of BRAs, SRMS, MA, SSAR, SER, and RMPs
- Performing peer review of NICSR literature
- Performing peer review of the deliverables authored by Medical Writers/Senior Medical Writers
- Reviewing PQ & SD Line Listing (LL) and completion of the Safety Signal Detection Supplemental Form (SSD SF)
- Interacting with the client's SL on the assigned reports
- Participating in weekly/biweekly product team meetings
- Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
- Ensure compliance of operations with governing regulatory requirements
- Create, maintain and assume accountability for a culture of high customer service
- Efficiency in conducting literature searches for authoring various types of reports
- Write various safety reports (or part of such reports) for global regulatory submissions for Sciformix's clients, including Annual Reports, Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports and other clinical documents as assigned.
- Write Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
Bachelors - Any Life Sciences
Strong previous Pharmacovigilance writing experience (including experience in authoring and reviewing of all sections of SSARs, RMPs, and periodic safety reports such as PBRERs, PSURs, and DSURs).
Preferably experienced in both aggregate and signalling activities.