Senior Clinical Safety Coordinator - Pharmacovigilance / Drug Safety Stirling, Scotland
Job description
At Medpace our European Pharmacovigilance (PV) activities are growing rapidly, as such we are searching for motivated individuals to join our Clinical Safety team. This position plays a key role in Clinical Safety at Medpace. Working as an integral part of a high performing Clinical Safety group, alongside our colleagues (Medical Monitors, Clinical Trial Managers…) to accomplish tasks and projects that are instrumental to the development of life changing medicines. If you want an exciting career where you can apply yourself to a variety of opportunities, develop new skills and develop even further, then this is the opportunity for you!
Where you’ll work
Based at either our Stirling or London office, Medpace offers hybrid working solutions upon completion of probation.
Company sponsorship in not available for this role.
Responsibilities :- Collect, process, and track serious adverse event (SAE) reports
- Generate safety narratives and queries
- Safety Database data entry
- Perform quality control of safety cases
- Generate Investigator Safety Letters
- SAE reconciliation between safety database and clinical database
- TMF uploads and quality control review
- Preparation of clinical safety documents as required (i.e., safety management plan, periodic safety reports and presentations)
- Attending internal and external meetings, as required (including sponsor TCs and audits/inspections)
- Leading clinical trial projects (ensure client deliverables are met, provide oversight and compliance reports)
Additional Responsibilities
Develop presentation material and present during face-to-face Sponsor meetings (i.e., Kick-off Meetings, Investigator Meetings)- Coordinate final medical review of study report narratives and submission to Medical Writers
- Develop drafts of adjudication material (i.e., charter, reporting materials)
- Provide periodic safety summaries to project Data Manager, Clinical Trial Manager, and Medical Monitor
- Train new Clinical Safety Coordinators on safety reporting responsibilities
- Coordinate safety responsibilities for aggregate reporting purposes (e.g., ensure timely data entry, tracking of pending cases, collaborate with Medical Monitor and Regulatory Affairs)
- Bachelor’s life science degree
- Experience in Pre-Market Clinical Trial Pharmacovigilance (4+ years)
- Working knowledge of Safety Databases (Argus is desirable)
- Demonstrate advanced knowledge of medical terminology, global safety reporting requirements and Good Clinical Practice (GCP) Guidelines
- Exposure to working on global trails as part of a multidisciplinary team
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 4,000 people across almost 40 countries.
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
Organic Growth: Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarters’ campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.
Perks:
Flexible work schedule- Medical and dental insurance
- Company pension scheme
- Cycle to work scheme
- Annual salary review
- Performance-based bonus
Awards:
Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer- Recognized by Forbes as one of America's Best Mid-size Companies in 2021
- Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
- Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati
What to Expect Next:
A member of our recruitment team will review your application and, if eligible will contact you for an interview.
EO/AA Employer M/F/Disability/Vets
