Teva Safety Scientist 

Croatia, Zagreb 

635209590

• Support the management of patient safety throughout different lifecycle stages of assigned Teva products, including retrieving and analyzing data to assist the review and evaluation of safety information (in collaboration with a Safety Physician, when applicable).
• Review and evaluate safety information associated with Teva products and provide medical and scientific input for (including but not limited to) Health Authority requests, signal evaluation documents and health hazard assessments.
• Participate in Product Safety Group (PSG) and coordinate all PSG related activities; support major safety issues escalations to senior safety governance committees as well as other forums attended by Teva’s senior management.
• Perform signal management activities related to assigned Teva products, including authoring of signal evaluations.
• Support risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, design of additional risk minimization measures (ARRMs) as well as management of these plans throughout the product’s lifecycle. Contribute to measuring effectiveness of ARRMs.
• Author safety analysis and responses to HA requests.
• Take part in preparing and providing training to newcomers or other MSU/PV members in different topics as required.
• Take part in and/or lead internal and/or cross-functional working groups, projects, and/or forums.
• Review portions of, and contribute to, the writing of periodic reports (PSUR, PADER, AR) involving assigned products.
• Consult and work with other functional teams both within and outside of PV to help define strategies and plans for important milestones and activities in assigned products.
• Support of data analytics related activities within MSU, including contributing to improving data quality in PV database and supporting data retrieval activities (e.g., generation of reports, QC support, modification of line listings/tables)
• Develop and maintain expertise in the relevant therapeutic area and assigned Teva products.

: fixed-term (two years).

• Bachelor’s degree in pharmacy, biology, veterinary medicine, nursing, paramedical studies degree or Pharm D
• Experience in patient safety/pharmacovigilance: solid knowledge in pharmacovigilance concepts, regulations and procedures
• Solid medical or pharmacological knowledge
• Advanced knowledge of Microsoft Office platforms
• Ability to work cross-functionally with an international team across multiple time-zones.
• Flexible to adapt to shifting team priorities
• Advanced communication skills in both spoken and written English

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