דרושים Safety Physician ב-טבע ב-Romania, Bucharest

• 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.

As anyou will conduct activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risk for the assigned products throughout the product lifecycle and provide comprehensive safety information to patients, prescribers, and regulators.

• Be 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 (such as Health Hazard Assessments, abbreviated safety evaluations, and Health Authority requests).
• Review complex Health Hazard Assessments and Health Authority requests.
• 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.
• 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 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. Conduct 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. Represent safety during due diligence of products.
• Collaborate with different functional internal (Medical Affairs, Clinical Development, Quality, etc.) and external stakeholers (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.

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• Clinical practice experience and/or epidemiological degree/training
• Experience working in pharmacovigilance and drug safety, as a safety physician –
• Proven ability to handle safety surveillance tasks and chair safety committee meetings
• Ability to serve as a subject matter expert
• Outstanding communication skills with an ability to collaborate with different departments and partner with and influence others without direct authority
• Ability to work cross-functionally within a matrix / international team across multiple time-zones
• Oral and written
fluency in English

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.