Safety Scientist jobs at Teva in Croatia, Zagreb

• Lead activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risks of assigned products throughout the product lifecycle including, as applicable, company sponsored studies, investigator sponsored studies, compassionate use, and disease monitoring programs.
• Lead and chair the cross-functional Product Safety Group. Be responsible for presenting decisions from Product Safety Group to senior safety governance committees as well as other forums attended by Teva’s senior management.
• Accountable for medical evaluation/interpretation of aggregate safety data of assigned products and non-assigned products, as required, including, but not limited to, signal detection and evaluation, dose escalation evaluations, regulatory safety reports (PSUR, PADER, DSUR), and ad-hoc safety review/assessments.
• Prepare and review complex Health Hazard Assessments and Health Authority responses.
• Perform signal management activities such as signal validation QC, authoring of complex signal evaluations, and signal evaluation review. Act as medical reviewer to assess causality, consolidate safety information from different sources to determine whether a signal qualifies as a risk.
• Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, design of additional risk minimization measures as well as management of these plans throughout the product’s lifecycle. The Safety Physician is responsible to define the important identified risks, important potential risks, and the missing information.
• Represent PV in cross-functional Product Label Working Group. Lead evaluation and determination of safety related sections of the product label, both initial and throughout the product lifecycle; key member for safety related label negotiations with regulatory agencies as well as in the development and maintenance of CCSI.
• Provide PV support and safety contributions to Health Authority submissions and responses.
• Collaborate with different functional stakeholders in Teva (Medical Affairs, Clinical Development, Quality, etc.) as well as outside Teva (KOLs, CROs, etc.) effectively representing PV position on any safety concerns as well as the overall safety profile of assigned products.
• Collaborate with other cross-functional teams to ensure execution of the safety strategy.
• Guide, provide support, and train, as applicable, safety physicians and safety scientists across safety surveillance activities such as medical review, signal detection, and risk evaluation activities.
• Represent safety during due diligence of products.
• Review and approve signal evaluation

• MD degree or equivalent; clinical practice experience and/or epidemiological degree/training is an advantage.
• Strong knowledge of FDA and EMA regulations (GVP, GCP)
• Previous Pharmacovigilance experience as Safety Physician
• Ability to work cross-functionally with an international team across multiple time zones.
• Fluent in English (speaking and writing)

• Analytical Skills: Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc.), assess clinical importance, evaluate the benefit risk ratio, and potential strategic impact of the data and present the findings clearly in both written and oral communications.
• Results and Performance-Driven: Assumes personal ownership and accountability for business results and solutions; consistently delivers results that meet or exceed expectations; makes the patient central to all thinking; keeps the focus on the value for patients (benefit/risk assessment). Holds himself/herself and others to the highest professional and ethical standards.
• Strong Interpersonal and People Skills: Ability to interact with individuals at a variety of functional levels with both internal and external personnel, and the ability to perform cross-functionally.
• Social Intelligence Capabilities: Being socially intelligent and understanding others' behavior are important skills when working in teams. The Safety Physician understands group dynamics, identifying and avoiding potential conflicts in a way that promotes everyone's interests and helps the team achieve its goals efficiently.
• Communication Skills, both written and oral: Communication style should be diplomatic and direct, but not confrontational. He or she must be able to summarize information in an articulate, clear, tangible, manner both in written form and orally. Ability to influence, negotiate and communicate with both internal and external stakeholders.
• Problem-solving Skills: Creativity and practical experience to solve problems that arise in the workplace.

• Competitive salary.
• Benefits packages with a great bonus system.
• Dynamic and professional atmosphere.
• Career development opportunities

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.

• 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.

• 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 speaking and writing English

Temporary, 1-year contract

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.

• Design and execution of Extractable and Leachable (E&L) studies, incorporating LC/UV/MS or GC/FID/MS analytical techniques.
• Development and validation of analytical methods incorporating Mass Spectrometry detection (LC/MS or GC/MS).
• Support the characterisation of polymer materials used in medical devices and packaging, including inhalation and injectable drug products, for both small molecules and biopharmaceuticals.
• Assist in the interpretation of Mass Spectrometry (MS) data as part of compound identification studies.
• Instigate and drive scientific and technical investigations developing multidisciplinary approaches to solve wide ranging and complex problems.
• Compilation and review of detailed technical documents.
• Deliver high levels of customer service (both internal & external)

• Temporary (maternity leave cover)

• Degree, Masters or PhD qualification in Chemistry (or related discipline), with minimum 3 year’s work experience with analytical method development and validation.
• Experience in analytical method development and validation with mass spectrometry is highly desirable.
• Experience with Empower and MassHunter software is highly desirable.
• Excellent communicator (both oral and written).
• Experience of working to current Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) and implementing policies and procedures in line with regulatory guidelines.
• Knowledge of regulatory and compliance requirements.
• Good planning and organising skills, adaptable to changing priorities.

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.