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Job Title: Senior Pharmacovigilance Quality Specialist Company: A Global Biotechnology Company Location: Hybrid with 2 days in the office in Maidenhead Hours: Full-Time Availability to start: ASAP Job Scope Perform quality control (QC) reviews to ensure documents produced by the Safety Surveillance and Aggregate Reports (SSA) team, or their vendors, meet high-quality standards. Support process improvements and contribute to additional SSA functions such as vendor management and SharePoint administration. Key Responsibilities • Conduct QC reviews of documents produced by the SSA team, including:, • Verifying source data to ensure all data and methodologies align with original source documents, including cross-checking text against database outputs., • Performing editorial, technical, and scientific reviews to ensure grammatical accuracy, stylistic consistency, and adherence to relevant style guidelines., • Documenting findings and providing clear feedback for authors to take appropriate corrective actions. Where necessary, collaborate with authors to review findings, determine next steps, and support development of revised content., • Review vendor-authored documents and QC activities as part of oversight responsibilities., • Support the development of training materials for new staff and vendors on quality standards., • Assist in preparing aggregate report quality trend analyses for team discussions., • Contribute to the development and maintenance of training materials and job aids., • Maintain and update SSA templates and QC checklists., • Support process improvement initiatives related to quality documentation and technical tools, including development of new templates., • Represent the department in cross-functional improvement initiatives where appropriate., • Perform administrative tasks such as maintaining tracking spreadsheets and communicating summaries and outcomes to relevant stakeholders., • Provide support across other SSA functions, which may include vendor management, aggregate reporting processes, SharePoint maintenance, and literature-related activities., • Train new team members and vendors on SSA quality requirements. Essential Skills and Qualifications • Experience: Minimum of 2–3 years’ experience in writing and editing within the pharmaceutical or biotechnology industry., • Prior experience in pharmacovigilance, medical writing, scientific editing, or publishing is also needed., • 2+ years experience in quality review, data checking against source material, and editorial oversight (grammar, formatting)., • Experience with safety documents (PSURs, DSURs, PADRs), • Advanced Microsoft Excel proficiency is non-negotiable (pivot tables, data verification)., • Excellent written English skills, with strong attention to detail and familiarity with medical terminology and the American Medical Association (AMA) Manual of Style., • Knowledge of pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations., • Understanding of case processing, expedited reporting requirements, and safety database concepts., • Ability to interpret, analyse, and clearly present scientific and medical data in both written and verbal formats., • Strong collaboration skills and ability to work effectively within a team environment., • Highly organised, with the ability to prioritise tasks independently., • Proficiency in common data processing and presentation tools (e.g., Excel, PowerPoint, Microsoft Word, Business Objects)., • Education: Bachelor’s degree in a biological or natural science, or a healthcare-related discipline.

Planet Pharma are currently partnered with a global pharmaceutical company and we are actively seeking a Pharmacovigilance Scientist to join the business in Slough. Key Responsibilities: • Perform quality control (QC) review of pharmacovigilance aggregate reports (e.g. PSURs/PBRERs, DSURs) to ensure accuracy, completeness, and compliance with regulatory requirements, • Verify consistency of safety data, tables, listings, and narratives across multiple data sources, • Ensure reports align with global regulatory guidelines and internal standard operating procedures, • Identify discrepancies, errors, or data gaps and provide clear, actionable feedback to authors, • Collaborate with cross-functional teams including safety scientists, medical writers, and data analysts to resolve QC findings, • Support timelines by prioritising QC activities and ensuring on-time delivery of high-quality reports, • Maintain documentation of QC activities, findings, and resolutions in accordance with compliance standards, • Contribute to continuous improvement of QC processes, templates, and best practices, • Assist in the preparation for audits and inspections by ensuring QC documentation is complete and inspection-ready, • Support training and guidance for team members on QC standards and expectations where required Key Requirements: • Degree in a related field (preferred), • 3+ years experience authoring aggregate reports About Planet Pharma: Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Please click ‘apply’ or contact Harry Banks at Planet Pharma for more information: E:

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Your new company My client is a leading biopharmaceutical company with a goal of contributing to healthcare innovation and environmental sustainability. They are focused on improving people's quality of life, specialising in Oncology, neurology, rare diseases, ophthalmology and immunology. There is an opportunity for a Pharmacovigilance Quality Document Associate to join their Quality Document Review team on an initial 12-month contract. Inside IR35 - PAYE or Umbrella Hybrid - 1-2 days on-site Maidenhead Your new role As a highly motivated individual, your primary focus as a Pharmacovigilance Quality Document Reviewer will be to perform QC (quality review) review to ensure documents authored by the Safety Surveillance and Aggregate Reports (SSA) team or their vendors are of high quality; support process improvement and other SSA functions (e.g., vendor management, SharePoint management). • Source data verification to ensure that all data and methods in all assigned documents agree with source documents, including checking text against database outputs., • Editorial, technical, and scientific reviews for grammatical and stylistic consistency and accuracy, • Provide document findings so that appropriate actions can be taken by authors. What you'll need to succeed • Hold a university degree in a life science or Healthcare - Writing and editing experience, within the pharmaceutical or biotech industry - medical writing, scientific editing and/or publishing. - Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts. Understands, interprets, analyses, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology). - Exceptional English writing skills, comfortable with medical terminology, and the American Medical Association Manual of Style. - Skilled with common data processing software (Excel, Pivot tables, PowerPoint, Microsoft Word, Business Objects). What you need to do now Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and living in the UK. If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on (phone number removed)

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