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 Bulgaria in collaboration with Global & Regional PV as well as local Commercial BU management.
How you’ll spend your day
- 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 Teva employees in Teva Bulgaria are familiar with the relevant Pharmacovigilance obligations, 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.
Your experience and qualifications
- University degree in Pharmacy, Medicine, or other life science relevant field;
- In depth knowledge of European and Bulgarian pharmacovigilance requirements;
- 4 years of relevant experience;
- Fluency in English, both written and spoken;
- Experience in leading teams and working collaboratively with stakeholders;
- Strong interpersonal and communication skills in cross-functional teams;
- Reliability and accountability;
- Strong analytical ability and a creative, solution-oriented style;
- Flexibility and ability to work in a fast-paced, rapidly changing environment on multiple projects with aggressive deadlines;
- Strategic thinking and high integrity, including strong ethical and scientific standards.
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