Senior Medical Safety Advisor (a 12-month fixed-term contract)
- Budapest
- Határozott idejű
- Teljes munkaidő
- Perform medical review and clarification of trial-related Adverse Events and post-marketing adverse drug reactions including narrative content, queries, coding, expectedness, seriousness, causality and company summary.
- Compose, edit and medically review Analyses of Similar Events for expedited cases as appropriate based on regulatory requirements.
- Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data.
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.
- Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
- Provide aggregate reviews of safety information, including but not limited to clinical data, post-marketing, literature review and observational studies to maintain oversight of a product’s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc).
- Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines.
- Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment.
- Ensure update of watch list, list of expectednesess, labeling list/RSIs etc for the assigned products.
- Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives.
- Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract.
- Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects.
- Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects.
- 24 hour medical support as required on assigned projects.
- A Medical Degree and 3 years of experience practicing clinical medicine
- At least 2 years of pharma experience
- Knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Knowledge of Pharmacovigilance- ICSR and Aggregate reports.
- In-depth knowledge of departmental standard operating procedures (SOPs).
- Skill in use of multiple safety databases
- Ability to establish and maintain effective working relationships.
- A valid medical license