The opportunity
We are looking for a qualified and motivated candidate for the role of Pharmacovigilance Manager (Local Safety Officer), based in Bucharest.
The main purpose of this position is establishing and maintaining a domestic Pharmacovigilance (PV) unit, being responsible for carrying out all PV activities as described in Global/Regional PV SOPs/WIs for Teva Romania in collaboration with Global & Regional PV as well as local Commercial BU management.
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 Romania 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.
• Doing 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.
