Teva Pharmacovigilance Manager Local Safety Officer 

Romania, Bucharest 

174884426

• Acting as contact point with the local health authorities regarding safety matters of Teva's products.• 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.

• University degree in Pharmacy, Medicine, or other life science relevant field
• In depth knowledge of European and Romanian 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, 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 working environment.
• Competitive remuneration bound with performance.
• Additional benefits.
• Flexible working hours and option to work from home as per the company policy.
• Opportunities 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.