Main responsibilities
Acting as contact point with the local health authorities regarding safety matters of Teva's products.
Establishing and maintaining working relationships with local departments, interfacing with PV and local external contractual parties (Teva’s 3rd parties/service providers) that may receive adverse events, special situations or other safety information, or impact on other PV activities (including but not limited to: Portfolio/Business development (BD), Legal, Regulatory Affairs (RA), Medical Affairs (MA), Quality Assurance (QA), Sales & Marketing, Customer Services, Reception, Digital engagement, PSP, etc.)
Ensuring that colleagues in Teva Hungary are familiar with the relevant Pharmacovigilance requirements, and that the PV activities and responsibilities are performed locally according to the required standard.
Ensuring that, when needed, appropriate out-of-office hours, back-up and business continuity arrangements are in place for the local PV activities.
Safety Reporting – collecting and processing Adverse Events/Adverse Drug Reactions (AEs/ADRs) and Special Situations from all sources in compliance with local and/or regional regulations and the applicable company SOPs and other.
Performing local literature search – ensuring that local literature search is done in addition to the Global literature search.
Periodic safety update reports (PSUR) and Company Core Safety Information (CCSI) – effectively collaborating with local Regulatory Affairs (RA) for alignment of local renewals in accordance with available periodic reports per Teva Periodic Reports & Risk Management Centre (TPC) planning and other.
Studies and other organized data collection schemes- being aware of all studies/other organized data collection systems (planned, active, completed) conducted in “Country.”
Risk Management Plans and Activities- ensuring that all necessary PV activities and any additional risk minimization activities required locally for all RMPs are agreed with local authorities and carried out on time and other.
Agreements – establishing a local process to ensure that PV is informed of new, updated or terminated PV-relevant commercial and service provider agreements, ensuring documented PV vendor selection (due diligence) is performed for 3rd parties performing PV-relevant activities and other.
Reconciliation and Corrective Action and Preventive Action (CAPA)
Regulations and Procedures – being up to date with relevant local and global regulatory requirements/SOPs and keep documented evidence of gap assessment against local legislation changes and other.
IT and PV system access – ensuring that electronic records relevant for PV are saved in a location covered by a local Disaster Recovery Plan (DRP) and other.
Candidate requirements
University degree in Pharmacy, Medicine, or other life science relevant field
In depth knowledge of European and Hungarian pharmacovigilance requirements
Minimum 4 years of relevant experience in Pharmacovigilance
Relevant experience in Regulatory, Quality, Clinical Trials areas would be a plus.
Fluency in English and Hungarian, both written and spoken
Experience in working with matrix teams and close collaboration with local and global stakeholders.
Strong interpersonal and communication skills in cross-functional teams
Working independently on PV-related topics
Analytical abilities and a creative, solution-oriented style
Flexibility and ability to work in a fast-paced, rapidly changing environment on multiple projects with tight deadlines.
Strategic thinking and high integrity, including strong ethical and scientific standards.
