Teva Pharmacovigilance Manager 

Bulgaria, Sofia 

858496657

• 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.

• University degree in Pharmacy, Medicine, or other life science relevant field
• In depth knowledge of European and Bulgarian 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 Bulgarian, 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

• Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
• Competitive remuneration bound with performance
• Additional healthcare insurance
• Transportation allowance
• Flexible working hours and option to work from home as per the company policy
• Opportunity for development

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.