Working for Symogen offers you a unique opportunity to gain experience and develop skills in the Pharmacovigilance sector. With a scope for versatility, initiative and creativity in a stimulating and supportive environment.
- Assist and support the medical and scientific functions within safety evaluations for assigned products including preparation and coordination of reviews of individual case safety reports as well as aggregate safety data including authoring and preparation of PSURs, CSR, PBRERs, ACOs and PADERs.
- Support and experience in writing Risk Management Plans and signal evaluation reports by serving as a coordinator for the acquisition and preparation of data for review from multiple sources. Collect, and/or organise the data collected as part of Pharmacovigilance plan, RMP, product recalls and surveillance activities and support physician in authoring of reports.
- Write clinical documents associated with submissions to regulatory authorities including but not limited to: model informed consents, interim and final clinical study reports, and safety update reports.
- Support physicians such as case series review, data review draft reports. Assist in organising or running search of safety or regulatory databases for the preparation of aggregate reports.
- Serve as the primary client contact under departmental supervision. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
- Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
- May participate in departmental or interdepartmental process improvement and training initiatives.
- Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
- Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to Symogen SOPs including: distribute drafts, chair review meeting, incorporate revisions, document key project events, and complete sign-off procedures.
- Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
Required education: Bachelor or Master degree or PhD in Life Sciences
Required experience: Medical Writing experience in (RMP,PSUR, PBRER, PADER) : 5 years
DRUG SAFETY ASSOCIATE
- Adverse event case entry and case processing, coding and narrative writing of serious and non-serious cases.
- Processing of adverse event reports from clinical studies, post-marketing studies, spontaneous, regulatory authority and literature report sources.
- Writing patient narratives.
- Coding of cases and identifying missing information.
DRUG SAFETY PHYSICIAN
- Provide medical review of individual case safety reports (clinical and spontaneous, serious and non serious), including coding, seriousness, expectedness and causality assessment for client products.
- Ensures that appropriate medical interpretation and consistency are applied to adverse event case assessment.
- Be the pharmacovigilance expert for assigned drugs or biologics, maintain current knowledge of full product portfolio and safety profiles for products.