Senior Project Lead, Patient Safety

Senior Project Lead, Patient Safety- Grade: P2-2 (Information for internal applicants)- Location: Greece, Italy, Portugal or Spain- 100% remote

Are you ready to take the reins of patient safety in diverse global projects?

As Senior Project Lead in Patient Safety Services, you'll guide a spectrum of studies, from high-volume Phase I trials to intricate global late-phase Oncology Studies. Are you excited to lead, collaborate, and make an impact on drug safety across multiple functions and regions?

Ready to amplify your leadership from regional to global impact?

Begin as a regional leader and evolve into a global influencer as you gain experience. Can you envision yourself spearheading critical patient safety operations and collaborating with stakeholders on an international scale?

Do you thrive in dynamic, client-focused environments?

Join us in this home-based position that connects you with cross-functional project stakeholders and our global Patient Safety team. Are you ready to be the driving force behind compliant safety reporting, communication, and harmonization to exceed client expectations?

Want to shape the future of patient safety with a leading CRO?

Fortrea invites you to contribute your extensive drug safety expertise. You will have the chance to influence safety management plans, interact with clients, and actively participate in shaping safety protocols for a range of products.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Duties and Responsibilities:
- Oversee the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.- Ensure compliant safety reporting in accordance with international reporting regulations, SOPs and safety processing guidelines, for assigned projects.- Supports preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, Development Safety Update Report (DSUR) Periodic Safety Reports (PSRs) line listings, and aggregate reports.- Begin to participate and demonstrate leadership on projects which enhance team and/or division performance. This may include acting as safety lead for projects at a global or regional level, ensuring communication and process harmonization.- Work with internal or external partners for reconciliation of safety databases, if appropriate.- Draft/modify and deliver safety presentations as required, to external and internal stakeholders.- Ensure compliant safety reporting in accordance with international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.- Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided.- Build and maintain good departmental relationships across functional units.- Support preparation of Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans under supervision.- Support the preparation of or prepare study specific job aids, instructions, training and templates.- Support systems set up during study start up and ongoing maintenance.- Assist functional safety lead in taking decisions regarding adverse event reporting within the guidelines of each specific project.- Assist the safety lead in TMF management activities.- Actively participate in project team and client meetings and liaise with clients, where appropriate.- Prepare and/or participate in internal, client or regulatory audits, and support other functional safety leads in audit preparation.- Assist with the provision of data to Safety Committees/DSMBs.

Experience Required:
- Extensive drug safety experience and operational knowledge ideally gained within a CRO or Pharma environment.- Knowledge of European PV regulations.- Experience with Argus or similar databases.- Strong relationship-building and interpersonal skills.- Ability to effectively balance multiple concurrent priorities in a fast-paced, complex setting.- Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.- Knowledge of medical and drug terminology.- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.- Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.- Knowledge of ICH guidelines.- Awarenes