SAFETY EVALUATION AND RISK MANAGEMENT PHYSICIAN (LV)

Hungary - Budapest

Tech People is a European provider of technical skills permanent recruitment and temporary contracting services for multiple industries.

Currently we are looking for

SAFETY EVALUATION AND RISK MANAGEMENT PHYSICIAN (LV)

Location: Budapest, XI., hybrid (2 days in office)

Salary: competitive

Type of employment: employee

Tasks:

Safety Governance and Risk Management
- Conduct and support pharmacovigilance and risk management planning.
- Contribute to benefit-risk assessments and regional Risk Management Plans.
- Provide medical/physician safety input into clinical development activities and key documents, including protocols, Investigator Brochures and informed consent forms.
- Support Safety Review Teams and the implementation of appropriate risk-reduction strategies.
Signal Detection, Evaluation and Labelling
- Perform routine signal detection and provide medical input into signal evaluation for assigned products.
- Evaluate safety and clinical data and discuss findings with key stakeholders.
- Provide recommendations and supporting documentation for labelling updates.
- Assess safety issues related to product defects, manufacturing issues and medication errors.
Regulatory Reports and Submissions
- Author and coordinate periodic regulatory reports, including PSURs and Annual Reports.
- Provide medical review and sign-off for periodic reports and renewal documentation.
- Support license renewals and contribute medical safety input to global regulatory submissions.
Other SERM Activities
- Review and contribute to Safety Data Exchange Agreements (SDEAs) and escalate identified deficiencies.
- Participate in project-related activities, audits and regulatory inspection readiness.
- Contribute to process improvement initiatives and development of safety methodologies.
- Escalate important safety concerns to senior management when required.
- Mentor and train junior scientists and provide medical safety support to Case Management activities.
- Review and approve safety reports to investigators together with the Clinical Development physician.

Requirments:

Medical degree
Minimum 5 years of clinical experience
Minimum 2 years of Pharmacovigilance experience within a Pharmaceutical Company or Contract Research Organization (CRO), including safety surveillance or signal detection activities
Experience across diverse therapeutic areas is preferred
Strong level of medical and clinical competence
Good knowledge of drug safety, clinical development, and ICH/GCP principles
Excellent written and verbal communication skills, with the ability to present and critically discuss clinical data in both internal and external discussions
Strong ability to evaluate, interpret, and synthesize scientific and clinical data, demonstrating analytical thinking
Good knowledge of MS Office
Excellent communication skills in English.
Candidate needs to be currently eligible to work in Hungary

To apply for this opportunity, please register your CV.