Delta PV, a leading pharmacovigilance service provider headquartered in Istanbul, Türkiye, has been part of the Biomapas group since 1 August 2025. As such, this vacancy is advertised on behalf of Delta PV within the Biomapas organization. The Pharmacovigilance Specialist will be responsible for ensuring the operational delivery of assigned tasks at the project level, with a focus on safety case reporting and the processing of safety case report data. The Specialist may assume the role of Primary or Secondary Project Responsible for the assigned project. The role involves communication with the Pharmacovigilance Team Leader and Pharmacovigilance Manager regarding potential risks related to operational delivery, quality standards, client relationships, and the company's reputation, as well as addressing ad hoc project tasks and requirements. The Pharmacovigilance Specialist may also contribute to the review and update of internal company procedures. Key Responsibilities: - Oversee and manage the workflow of safety case reports, ensuring efficient processing. - Perform triage on safety case reports to assess priority and necessary actions. - Review, manage, and file source documentation in compliance with regulatory requirements. - Process safety case reports, including SDB data entry, narrative writing, seriousness assessment, medical review (including causality and expectedness assessments), and reporting requirements evaluation. - Conduct follow-up activities and manage queries related to safety case reports. - Execute quality control checks on data entry and case processing to ensure accuracy and compliance. - Reconcile safety case reports to ensure consistency and completeness of data. - Prepare line listings to summarize and report on safety case data.

Delta PV, a leading pharmacovigilance service provider headquartered in Istanbul, Türkiye, has been part of the Biomapas group since 1 August 2025. As such, this vacancy is advertised on behalf of Delta PV within the Biomapas organization. The Pharmacovigilance Specialist will be responsible for ensuring the operational delivery of assigned tasks at the project level, with a focus on safety case reporting and the processing of safety case report data. The Specialist may assume the role of Primary or Secondary Project Responsible for the assigned project. The role involves communication with the Pharmacovigilance Team Leader and Pharmacovigilance Manager regarding potential risks related to operational delivery, quality standards, client relationships, and the company's reputation, as well as addressing ad hoc project tasks and requirements. The Pharmacovigilance Specialist may also contribute to the review and update of internal company procedures. Key Responsibilities: - Oversee and manage the workflow of safety case reports, ensuring efficient processing. - Perform triage on safety case reports to assess priority and necessary actions. - Review, manage, and file source documentation in compliance with regulatory requirements. - Process safety case reports, including SDB data entry, narrative writing, seriousness assessment, medical review (including causality and expectedness assessments), and reporting requirements evaluation. - Conduct follow-up activities and manage queries related to safety case reports. - Execute quality control checks on data entry and case processing to ensure accuracy and compliance. - Reconcile safety case reports to ensure consistency and completeness of data. - Prepare line listings to summarize and report on safety case data.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. FSP CRA (Sponsor: GSK) ─ with Sign-on Bonus As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. What You’ll Do: • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. • Participates in investigator meetings as necessary. Identifies potential • investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. • Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. • Contributes to other project work and initiatives for process improvement, as required. Education and Experience Requirements: • Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. • at least 1-2 years of independent monitoring experience in clinical development phases I-III • Understanding of ICH-GCP, KGCP requirements • Fluency in English Knowledge, Skills and Abilities: • Proven clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills, with the ability to communicate effectively with medical personnel • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues • Good organizational and time management skills • Effective interpersonal skills • Attention to detail • Ability to remain flexibile and adaptable in a wide range of scenarios • Ability to work in a team or independently as required • Good English language and grammar skills • Good presentation skills

Consult with researchers on data needs, design protocols for data management, provide technical support for integrating standards, and mentor team members to enhance biodiversity research capabilities.