Quanticate

• Review and assess individual case safety reports, including medical accuracy checks, narrative review, coding verification, assessment and provision of medical causality comments. • Support signal detection activities through regular review of aggregate data. • Provide medical input into periodic safety reports such as DSURs and PSURs. • Review and contribute to project‑specific Safety Plans and other pharmacovigilance (PV) documents. • Provide medical consultancy for pre‑ and post‑marketing activities including study design, protocols, investigator brochures, core safety information and risk management plans. • Support medical monitoring across clinical studies, including review of study documents, training of project teams and contributions to regulatory and ethics submissions. • Attend investigator meetings and Data Monitoring Committee meetings when required. • Provide ongoing medical data review covering adverse events, laboratory results and physical examinations. • Offer guidance to investigators and study teams, including emergency unblinding for safety concerns when necessary. • Provide 24/7 medical contact as required and liaise directly with sponsor teams.

Role Description Quanticate International is hiring a Pharmacovigilance (PV) Consultant Physician to support clinical and post‑authorisation safety activities for global pharmaceutical and biotech clients. This position provides medical review and specialised input across safety reporting, medical monitoring, and regulatory documentation. You will work within established procedures and quality standards while applying medical judgement across multiple projects. This is a fully remote position but applicants need to be based in the UK and also be happy with zero hour contract. Key Responsibilities - Review and assess individual case safety reports, including medical accuracy checks, narrative review, coding verification, assessment and provision of medical causality comments. - Support signal detection activities through regular review of aggregate data. - Provide medical input into periodic safety reports such as DSURs and PSURs. - Review and contribute to project‑specific Safety Plans and other pharmacovigilance (PV) documents. - Provide medical consultancy for pre‑ and post‑marketing activities including study design, protocols, investigator brochures, core safety information and risk management plans. - Support medical monitoring across clinical studies, including review of study documents, training of project teams and contributions to regulatory and ethics submissions. - Attend investigator meetings and Data Monitoring Committee meetings when required. - Provide ongoing medical data review covering adverse events, laboratory results and physical examinations. - Offer guidance to investigators and study teams, including emergency unblinding for safety concerns when necessary. - Provide 24/7 medical contact as required and liaise directly with sponsor teams. Qualifications - Medical Doctor qualification. - Experience in clinical practice and medical monitoring. - Strong background in pharmacovigilance, including ICSR triage, medical review and aggregate reporting. - Clear communication skills with the ability to explain clinical reasoning. - Strong organisational skills, attention to detail and comfort working to tight timelines. - Good understanding of ICH GCP and relevant safety regulations. - Proficient in Word, Excel and standard PC tools. Benefits - Be part of a knowledgeable global team and contribute to important drug safety work. - Varied project exposure and professional growth. - Opportunity to apply clinical expertise within an established CRO environment. - Career development support, including membership to professional societies. - Encouragement of involvement in activities and committees.

Role Description We are seeking an experienced Senior Proposals Manager to provide high-level support to our sales and operational teams and to play a central role in driving top-line growth. This role leads the Proposals function, ensuring the delivery of accurate, high-quality budgets and proposals through robust tools and processes. This is not a line management role but will work closely with senior stakeholders so communication across teams is key. For this role you MUST have experience in the Life Sciences industry. You will work closely with the Global Business Development team, operations, finance, and senior stakeholders to develop competitive, compliant bids, budget and pricing strategies. You will also be responsible for managing and continuously improving proposal-related processes. Key Responsibilities - Prepare high-quality budgets and proposals to support global business development activities. - Review and quality-check all study budgets, proposals, RFIs, and related client responses prior to submission. - Partner with Heads of Function to define bidding strategies, including operational and pricing approaches. - Support account management and operational activities, including business wins and revenue recognition. - Maintain and oversee sales and finance tracking tools to ensure accurate pipeline reporting. - Own and manage the opportunity management system, including Salesforce. - Contribute to and deliver training for sales and operational teams on bidding procedures and process compliance. - Lead, train, and develop the Proposals team, setting clear standards and expectations. - Support the development and implementation of new tools and processes to enhance proposal efficiency and quality. This is an opportunity to take ownership of a critical commercial function and make a visible impact on business growth within a collaborative, fast-paced environment. Qualifications - Degree qualified or equivalent. - MUST HAVE: Significant experience preparing full-service clinical proposals within a CRO environment. - Strong commercial awareness with a proven ability to manage complex proposals and budgets. - Experience with multiple pricing models and client bid grids. - Background in a commercial or service-led organization, within life sciences or pharmaceuticals. - Highly organised, deadline-focused, and comfortable managing competing priorities. - Strong written and verbal communication skills with excellent attention to detail. - Confident interpersonal style with a professional telephone manner. - Fully IT literate, including standard office applications and CRM systems. - Personal drive, presence, and enthusiasm, with the ability to lead and motivate others. Benefits - Competitive Salary (Open to discussion based on experience) - Home working allowance - Flexible working hours - 25 days Annual leave plus bank holidays - Option to purchase additional days holiday - Pension with Company matching - Private medical Scheme with Bupa - Free standard eye test every two years - Employee Assistance Program – Available for employee and immediate family - 5, 10, 15 years of service recognition awards - Death in service scheme - Long Term Disability Insurance - Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e-learning, job shadowing)

• Prepare high-quality budgets and proposals to support global business development activities. • Review and quality-check all study budgets, proposals, RFIs, and related client responses prior to submission. • Partner with Heads of Function to define bidding strategies, including operational and pricing approaches. • Support account management and operational activities, including business wins and revenue recognition. • Maintain and oversee sales and finance tracking tools to ensure accurate pipeline reporting. • Own and manage the opportunity management system, including Salesforce. • Contribute to and deliver training for sales and operational teams on bidding procedures and process compliance. • Lead, train, and develop the Proposals team, setting clear standards and expectations. • Support the development and implementation of new tools and processes to enhance proposal efficiency and quality.

• Perform standard non-compartmental pharmacokinetic analyses for Phase I clinical studies • Generate and review PK parameters including Cmax, Tmax, AUC, and half-life • Contribute to PK tables, listings, figures, and summary outputs for clinical study reports • Support analyses across SAD, MAD, and food-effect study designs • Assist with dose proportionality and exploratory PK comparisons where required • Ensure appropriate handling of below-quantification-limit (BQL) data according to SAP guidance • Conduct independent quality control of PK datasets and analysis outputs • Peer review analyses performed by other statisticians or programmers • Document QC findings clearly and support issue resolution in line with SOPs and good statistical practice • Review PK components of protocols and SAPs to confirm feasibility and internal consistency • Ensure analyses are performed according to specifications and document any assumptions or deviations • Support resolution of PK-related analytical queries • Work closely with bioanalytical, clinical pharmacology, clinical operations, and biometrics teams • Support integration of PK outputs into clinical study reports alongside safety and tolerability data • Liaise with programmers, statisticians, and medical writers to ensure traceability and consistency of deliverables • Participate in scientific discussions with internal teams and external sponsors as required • Support knowledge sharing related to PK analysis best practice • Contribute to development and improvement of PK analysis and QC workflows

• Designing and analysing clinical studies, including input into protocols, Statistical Analysis Plans and sample size calculations • Programming and quality controlling derived datasets and CDISC compliant datasets • Producing and reviewing Tables, Listings and Figures • Providing peer review of statistical and programming deliverables • Ensuring all outputs meet internal SOPs, client requirements and regulatory expectations • Manage assigned project work independently, communicate clearly with sponsors when required, and flag risks that could affect timelines or data quality • Line manage assigned team members, providing mentorship, training and performance feedback

• Lead the preparation, authoring, review, and updating of Risk Management Plans (RMPs) for regulatory submissions and post-approval activities. • Develop RMPs in support of Marketing Authorisation Applications (MAAs) and variations. • Ensure RMPs comply with regional pharmacovigilance and regulatory requirements. • Collaborate with cross-functional teams including Regulatory Affairs, Clinical Development, Medical Affairs, Safety, and Quality. • Provide strategic pharmacovigilance input regarding safety concerns, risk minimisation measures, and pharmacovigilance activities. • Support responses to health authority questions related to risk management and pharmacovigilance documentation. • Contribute to the continuous improvement of pharmacovigilance processes and documentation standards.

- Program tables, figures and listings and derived datasets according to the request description. - Perform quality control checks and complete quality control documentation for programming plans, specifications, outputs/derived datasets. - Perform other reasonable programming tasks as requested by management. - Follow appropriate Project Management procedures. - Communicate effectively with OR team. - Provide input to improvements to processes, procedures and standards. - Support the training and development of other programmers.

Role Description Unlock Your Future in Life Sciences Programming at Quanticate! Are you a skilled SAS Programmer with a strong grasp of SQL? Ready to leverage your technical expertise in impactful Real World Evidence (RWE) life science projects rather than finance or other industries? Join Quanticate, one of the world's leading data-focused CROs, where you’ll contribute to some of the most advanced clinical programs across the globe. - Be a part of projects that contribute to the advancement of therapies that genuinely make a difference in patients' lives. - Work as an integrated team member on world-leading clinical programs for top global pharmaceutical companies. - Engage with small biotech companies that are taking their first steps in clinical development. - Participate in career development through membership to professional societies and involvement in their activities and committees. - This is a fully remote role but candidates must be based in UK or Poland due to employment contracts. Responsibilities - Program tables, figures, listings, and derived datasets according to the request description. - Perform quality control checks and complete quality control documentation for programming plans, specifications, outputs/derived datasets. - Perform other reasonable programming tasks as requested by management. - Follow appropriate Project Management procedures. - Communicate effectively with the OR team. - Provide input to improvements to processes, procedures, and standards. - Support the training and development of other programmers. Objectives - Further development of knowledge of SAS and advanced SQL, good programming practices, and numerous Real World Data (RWD) databases. - Ensure high levels of customer care are provided. - Review available resources to find required information. - Use and manipulate data stored in SQL database. - Ability to understand and modify SAS macros. - Use longitudinal databases (Administrative medical and pharmacy claims databases, Electronic Medical Records). - Technical experience in handling large datasets. - Basic understanding of statistical models used in Outcomes Research (OR). - Ability to ask questions effectively. Qualifications - Extensive knowledge of statistical software packages (particularly SAS). - Extensive knowledge of SQL. - Qualified to degree level or equivalent, preferably in a numerate discipline. - Experience with large datasets, ideally Medical data - Healthcare databases, Payer databases, Hospital records. - Should have PC skills. - Good organisational skills, communication skills (oral and written). - Good analytical skills and attention to detail. Benefits - Private medical care. - Life insurance. - Flexible working time. - Full-time home working.

• Lead, support, and develop team of Internal Recruiters • Manage recruiter performance, workload allocation, and delivery against hiring objectives • Partner closely with the CEO to support and implement recruitment strategies • Act as a key point of contact for recruitment-related queries • Build strong working relationships with hiring managers and stakeholders across the business • Manage end-to-end recruitment processes for assigned permanent and contract vacancies globally • Develop a strong understanding of role requirements, candidate profiles, technical skill sets, and business needs • Source candidates using a variety of methods including advertising, direct sourcing, networking, database searching, social media, and talent mapping • Conduct candidate screening interviews and assess suitability prior to submission to hiring managers • Coordinate interviews, assessments, and recruitment activities to ensure efficient hiring decisions • Ensure candidates are fully prepared throughout the recruitment and interview process • Build and maintain talent pipelines for current and future hiring needs • Develop and maintain strong relationships with prospective candidates in the market • Provide market insights and recruitment intelligence to internal stakeholders • Stay up to date with recruitment trends, sourcing techniques, and market developments within life sciences and pharmaceutical sectors • Ensure accurate and timely tracking of recruitment activity within the ATS • Collaborate closely with HR to ensure a seamless onboarding experience • Support employer branding and recruitment marketing initiatives • Represent Quanticate at careers fairs, conferences, and networking events where required • Become a subject matter expert in internal recruitment and employer branding best practices