Drug Safety Physician
The position engages in the technical activities performed within the Drug Safety department and works also cross-functionally, providing medical support and assistance with technical activities to other units within the PV department.
The Safety Physician is involved in continuous safety assessment, evaluation and risk management of products under Arriello’s responsibility (where Arriello is MAH or Arriello performs activities on behalf of Clients, further as “Arriello products”). The Safety Physician also executes project related tasks and activities and ensures a high quality of the services provided.
Within Arriello, they are a subject matter expert, supporting our delivery teams with learning, and they are involved in helping us identify technology or changes to our business, to support our client and regulatory needs.
What will be your key responsibilities:
- Involved in the evaluation of adverse events and adverse drug reactions and other safety information on Arriello products
- Provides medical support to the EU QPPV/deputy EU QPPV and Pharmacovigilance department employees
- Maintains current knowledge on the safety profiles of assigned medicinal products
- Has an overview and supports the continuous evaluation of the benefit-risk profiles of assigned medicinal products
- Provides support in the preparation and review of CCDS/SmPC/PIL as/if required
- Performs medical reviews of individual case safety reports (ICSRs) (e.g., causality and expectedness assessment, seriousness assessment, review of MedDRA coding, clinical evaluation)
- Performs medical reviews of cases from clinical trials (AEs/SAEs/SUSARs/SADRs); (e.g., causality and expectedness assessment, seriousness assessment, analysis of similar events (AoSE), review of MedDRA coding, clinical evaluation, case narratives review)
- Provide medical expertise and participates in signal management activities
- Provide medical input into Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR)
- Provide medical input into Risk Management Plans (RMP)
- Participates in the preparation of responses to Competent Authority requests (i.e., EMA, NCAs) as required
- Provide medical expertise in handling of on Emerging safety issues
- Maintain knowledge of current PV and related regulations (i.e., Good Pharmacovigilance Practice)
- Prepares training materials and performs training on medical related issues both internally and to Clients/Partners/Vendors as required
- Serves as a company medical expert
- Local project management (Local literature monitoring, Local ICSR processing, LPPV/LSO management, Monthly reporting and compliance monitoring);
- Processing of safety reports (AEs/SAEs/SUSARs) including from those from clinical trial and post-marketing sources– receipt, triage, safety database entry, quality control, MedDRA and WHO drug coding, expectedness and seriousness assessment, classification, tracking, coordination of medical review and assessment, follow-ups, as required;
- Support expedited submission of ICSRs to concerned parties
- Support the reconciliation of safety reports with the clinical database
- Support periodic screening and evaluation of local country reporting requirements
- Global Literature monitoring;
- Medicinal Product Management (XEVMPD);
- Product documentation (SmPC, IB);
- Management of project related PV contracts (PV service agreements, Safety data exchange agreements);
- Support the development and revision of Safety Management Plans
- Support the revision of clinical safety documentation (e.g. reconciliation plans, study protocols, IBs, SAE forms, pregnancy forms)
- Regulatory Intelligence, Signal Management and Benefit Risk Management activities;
- Support provision of pharmacovigilance training to project and internal teams as well as other departments
- Improvement of processes within the assigned Unit, ensuring a smooth run of the project, tasks and processes; ability to capture all running projects, tasks and processes within the unit and their relations to other units within the PV department
- Escalate technical project issues to Project Managers for their given projects
Language: English (C2)
For graduates: no
Salary: by agreement
- Hybrid or remote working (Use of our offices in various locations, co-sharing workspace or home office options)
- 5 weeks holiday plus national holidays in your given location
- 3 personal days
- Flexible benefits, based on location
- Home office stipend
- Annual bonus program
- Other employee Bonuses (spot bonuses and employee nominated bonuses)
- Dog friendly offices
What experience should you have:
- Bachelor’s degree or graduate in pharmaceutical sciences or related fields (medicine, pharmacy, life sciences) – advanced degree (e.g., masters) preferable
- Previous knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.,) beneficial
- Fluent verbal and written English
- Excellent team player, able to build an effective team
- Organizational and time-management skills, able to prioritise work and adhere to deadlines
- Excellent communication skills
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