Respond to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over the telephone call, email, fax etc Execute drug safety data management processes - a combination of call intake, call dialogue documentation, peer review, case follow-up. Perform and support different activities as assigned - tracking several types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Create and revise training materials based on procedural, system, and regulation updates. Responsible in conducting trainings and checks the effectiveness of the trainings as required. Assume responsibility for quality of data processed. Any other duties as assigned by management. And all other duties as needed or assigned. Qualifications (Minimum Required): bachelors or Masters in Pharmacy or Life Science or Medical Science or related area + 2 to 3 years of safety experience. BS/BA + 2 to 3 years of safety experience. MA/MS/PharmD + 1 to 2 years of safety experience. Associate degree + 4-5 years relevant experience** (or 2+ years safety experience) * Non degree + 5-6 years relevant experience** (or 2+ years safety experience) * Fortrea may consider relevant and equivalent experience in lieu of educational requirements. *Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance. Fluent in English, both written and verbal. Experience (Minimum Required): Experience in call center operations is preferred Preferred Qualifications Include: Degree preferred (but not necessarily) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry. Good written and verbal communication skills. Ability to receive and manage in-bound and out-bound calls. Ability to analyze and synthesize medical information. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines. Technical proficiency with Microsoft Office suite applications. High degree of accuracy with attention to detail. Functions as a team player. Ability to work independently with moderate supervision.

Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing settings (ie, unsolicited reports) Manage and process expeditable adverse events to the required standard and submit them to the client and/or the regulatory agencies (if required) within the agreed/stated timelines Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and costeffective manner The role will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company s Health and Safety Manual

PDE / OEL calculation and report preparation OTC / Self-care formulas safety assessment Raw material safety assessment Extractable and Leachable safety assessment Impurity qualification INCI-Tox.Profile preparation for OTC / Self-care ingredients Authoring Non-Clinical Overview: Module 2.4 Toxicology literature review and report preparation

Lead the development and implementation of solutions to global technical services issues and concerns regarding EDC tools like Medidata RAVE or Oracle Inform or Data/Report programming or Visual Analytics tools like Spotfire or Tableau. Develop/validate Custom/Complex SAS / SDTM datasets and efficiently handle external data and reconciliations. Perform any postproduction changes to the EDC database or enhancements to the SAS programs like SAS edit checks, listings, Protocol Deviations, SAS Datasets etc, Conduct Peer Review/Quality control of study design for assigned projects. Summary of Responsibilities: Lead the development and implementation of solutions to global technical services issues and concerns regarding SAS or Python or Data/Report programming or Visual Analytics tools like Spotfire or Tableau. Develop/validate Custom/Complex SAS / Python/SDTM datasets and efficiently handle external data and reconciliations. Perform any post production changes to the SAS/Python programs edit checks, listings, Protocol Deviations, Datasets etc, Conduct Peer Review/Quality control of study design for assigned projects. Lead the development and implementation of Clinical solutions to global technical services issues and concerns regarding SAS programming. Lead the development of visual analytics dashboard using tools like Spotfire/Tableau. Complete assigned work utilising SAS, Python, SAAMA or other proprietary software according to Fortrea SOPs, Work Instructions, and project specific guidelines in accordance with Good Clinical Practices. Perform any post-production changes to the enhancements for SAS programs like SAS edit checks, listings, Protocol Deviations, etc, With assistance, meet with Data Manager on assigned projects to discuss contractual obligations and timelines. Act as Subject Matter Expert (SME) and be point of contact for any technical services, issues related to SAS programming. Serve as Lead Statistical Programmer providing programming support for development and maintenance of SDTM/Client standards datasets. Develop/validate Custom/Complex SDTM domains and efficiently handle external data and data reconciliations. Develop and implement SDTM automation/standardization and best programming practices across projects to enhance quality and productivity. Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, meeting timelines, maximizing quality, interaction with other departments and the client, etc Exhibit good imparting, analytical skills along with testing, troubleshooting, error fixing, and documentation skills. Participate in the ongoing review of the processes used to ensure adaptation of best practices. Conduct Peer Review/Quality control of study design for assigned projects. Able to work independently and take initiative to accept new challenges in Clinical Programming Applications, also participate in the validation of new or updates to software. Resource forecasting and allocate activities to the team members on the project. Generate reports/metrics or demonstrate programming process to sponsors/auditors (if required), assist with the design of study documents. Perform other duties as assigned by Manager. Qualifications (Minimum Required): University / college degree (life sciences, health sciences, information technology or related subjects preferred). Experience and/or education plus relevant work experience, equating to a bachelors degree will be accepted in lieu of a bachelors degree. Fluent in English, both written and verbal. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): 5 to 8 years of relevant work experience to include data management and database support or SAS Programming or Spotfire or Tableau development. Good problem-solving skills and a proactive approach. Good oral and written communication skills. Basic knowledge of clinical trial process and data management, biometrics, and systems applications to support operations preferred. Demonstrated ability to work in a team environment. Demonstrated ability to work independently under supervision. Proven interpersonal skills. Physical Demands/Work Environment: Office work environment