Sr Mgr PhV Safety Physician

4 weeks ago

Bengaluru, India Teva Pharmaceuticals Full time

The opportunity

The Safety Physician leads the safety profile of specific medicinal products assigned to him/her throughout various stages in the product lifecycle. In partnership with other Teva stakeholders, the Safety Physician identifies and defines the risks of Teva's drugs and proposes measures to monitor, minimize, or mitigate them. The Safety Physician ensures a positive benefit-risk ratio is maintained throughout the product lifecycle and provides comprehensive safety information to patients, prescribers, and regulators.

How you’ll spend your day

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 (such as Health Hazard Assessments, abbreviated safety evaluations, and Health Authority requests). Review of 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. 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.

JD to be Contd.

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

Your experience and qualifications

MBBS/MD degree or equivalent; clinical practice experience and/or epidemiological degree/training is an advantage. Strong knowledge of FDA and EMA regulations (GVP, GCP) Ability to work cross-functionally with an international team across multiple time zones. Fluent in English (speaking and writing) MCI is must Min 4 to 5 years relevant experience in Signal Detection in Pharmacovigilance Experience in ICSR/ medical Review

Job-specific competencies

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.

to be contd.

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.

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