Safety Scientist
Zagreb, Croatia, 10000
Who we are
The opportunity
Teva Pharmacovigilance unit is hiring for a Safety Scientist, Pharmacovigilance Associate III role to join the Medical Scientific Unit (MSU) and support safety in Teva’s innovative product in collaboration with a Safety Physician. In the MSU, we lead drug safety across the entire Teva portfolio and throughout various stages in the product lifecycle. MSU Safety Scientists possess exceptional analytical skills and perform medical and scientific data retrieval, review, and analysis to support multiple activities (e.g. signal management, health hazard assessments etc.). The Safety Scientists work in collaborative manner with a cross-functional international team across multiple time zones, operate well in a stressful environment, and quickly adapt to shifting team and project priorities.
How you’ll spend your day
- 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
- Develop and maintain expertise in the relevant therapeutic area and assigned Teva products
Your experience and qualifications
- 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 proficiency in spoken and written English
Already Working @TEVA?
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