Safety Surveillance Scientist
Are you experienced in the pharmaceutical industry?
Would you like to join a multicultural team of over 100+ professionals which develops a new drug that helps humankind live freely?
We are starting a new project in Pharmacovigilance, which is a reasonably new business area in Hungary.
Responsibilities:
- Assisting physicians in maintaining up to date knowledge of the products assigned with focus on safety.
- Revising aggregate case reports from the relevant safety database and other sources as applicable, using client’s relevant designated safety surveillance tool.
- Conducting initial evaluation of safety signals from routine review of cumulative safety data and document outcome according to specified criteria and requirements.
- Documenting potential signal and related information as per specified criteria and requirements. Maintaining surveillance action log up to date.
- Preparing training material, conduct and assess periodic and need based trainings as and when required.
- Ensuring compliance with global and local procedural documents and local implementation of the client Patient Safety objectives, policies, procedures and processes.
- Notifying surveillance team of any safety signal that may require urgent evaluation and action.
- Conducting further evaluation of safety signal as required by the client, if applicable
- Providing ongoing training on the updated SSP, routine signal management requirements, product safety profiles and updated safety signal evaluation criteria for new hires.
- Participating in conducting gap analysis and identify the remedial actions for the improvement of quality of deliverables as and when required.
Requirements:
- Healthcare professional (Life sciences Graduate and Post-graduate) with more than one year of Pharmacovigilance experience at a Pharmaceutical Company or Contract Research Organization (CRO) including safety surveillance or signal detection activities.
- High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
- Knowledge of drug safety and clinical development and ICH/GCP principles.
Advantage:
- Knowledge of pharmacovigilance practices, particularly in relation to signal detection and evaluation.
- Knowledge of global Pharmacovigilance regulatory requirements.
What we offer:
- Being part of the Top 10 Pharma company partner
- Working in an international, young and dynamic team
- Opportunity to work and deepen your knowledge in the field of Pharmacovigilance – Drug Safety
- Remote work (Home office)
- Flexible working hours
Sector (s):
- Healthcare, Pharmaceutical Industry
- Healthcare Specialist
- Pharmacist
Experience required:
- 1-5 years’ professional experience
Required Qualification:
Required language level:
- English (higher advanced/fit for negotiation)
Employment type:
If you are interested, send your English CV to info@foxhr.hu
