Senior Project Lead Pss

**Senior Project Lead, PSS**:

- **Grade: P2-2**
- ** Locations: Spain, Bulgaria, Italy, Portugal or Romania**
- **100% remote**

As Project Lead Patient Safety Services you will be responsible for leading projects across our Drug Safety portfolio. These can vary from Phase I, high volume fast paced studies through to large global late phase complex Oncology Studies. You will have the opportunity to act as the regional lead and as you become more experienced take this responsibility into a global stage.

This is a home based position but you will work closely with key project stakeholders across multiple functions as well as our global Patient Safety Service team.

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

You will coordinate and oversee the overall PSS operations associated with the processes for adverse events and expedited safety reports to the required standard and ensure submission of them to the client and the regulatory agencies (if required) within the agreed/stated timelines.

**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.
- Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.

**Education/Qualifications**:
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.

**Did you know?**:
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