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.
Quality Assurance Associate
- Maintain document management system.
- Coordinate initiation/revision, review and approval of controlled documents.
- Set up system for staff to request creation of or changes to controlled documents.
- Log controlled documents.
- Assign numbers to controlled documents.
- Update and maintain log as changes are made to controlled study documents.
- Monitor access to controlled documents (i.e., “in/out procedure, restricted access).
- Maintain all original versions of controlled documents to track the history of changes.
- Coordinate space for secure and restricted storage of study documents and records.
- Ensure training files are complete and up-to-date for all staff.
- Assist with tracking completed training per established process (e.g., database, spreadsheet, etc.).
- Inform management on areas of additional training, retraining or refresher training for staff based on monitoring and auditing activities.
- Manage deviation reporting with corrective action/preventative action (CAPA)-
- Identify deviations through monitoring activities.
- Log deviations using appropriate tool (e.g., database, spreadsheet, etc.).
- Inform staff on how and when to report deviations
- Collect and ensure completion of CAPA Form
- Follow-up on CAPAs
- Assess trends and conduct investigations
- Assist with internal and External audit procedures
- Schedule and conduct audits of targeted system or process for compliance with ICH Guidelines, SOPs, GVP and other written procedures
- Actively lead or assist in planned and for cause activities for quality investigation, evaluation and improvement.
- Participate in solving compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance departments.
- Lead internal QMS auditing activities to ensure compliance with applicable GxP industry guidelines, and agency regulations. Audits to include vendors, internal GxP systems, processes and procedures as required.
- Develop and maintain Company audit schedules.
- Track audit findings and outcomes, as applicable.
- Conduct follow-up activities/ performance evaluation to assure that non-compliance issues are addressed with satisfactory resolution.
- Author, review and approve QMS related SOPs, policies, guidelines, protocols and reports and other documentation as appropriate.
- Report quality deficiencies and/or risks to Management as appropriate.
- Coordinate and manage internal staff training. Assist in documentation and tracking of project related training as required.
- Produce and deliver QMS and other training material as required.
- Perform other related duties as assigned.
- Assist with management of contract auditors.
- Actively lead or assist in planned and for cause activities for quality investigation, evaluation.
- Candidates should have a scientific degree (BSc, MSc, Pharmacy, PhD) and at least 2-3 years of QA experience
- Demonstrate basic computer and Internet skills (MS Excel, MS Project and MS Word, or equivalent, spreadsheets, databases)
- Location: UK & India Offices
- 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 PHYSICIAN
- Location: UK & India Offices
- 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.