Senior Global Program Safety Team Lead job opportunity at Novartis.

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DateMore Than 30 Days Ago bot
Novartis Senior Global Program Safety Team Lead
Experience: 7-years
Pattern: full-time
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degreeMaster's (M.A.)
loacation Hyderabad (Office), India
loacation Hyderabad (Off..........India

Job Description Summary The Sr. GPSL-TL serves as strategic leader of the Medical Safety organization to improve patients’ lives and impact on overall Novartis results through robust safety risk management. This role requires an experienced and knowledgeable safety clinician responsible to predict safety risks and assess scientific information to guide the assigned teams on strategic considerations, effective risk management and overall positive impact in development programs. Ensures optimal patient safety for assigned compounds, is responsible for the integration, analysis, and interpretation of internal and external safety information from all sources through lifecycle management. This is a management position requiring excellent collaboration skills and matrix leadership, who will work closely with the Head Patient Safety managing complex safety issues across several indications.   Job Description Major accountabilities: Manages an efficient and successful disease area within the TA/DU Medical Safety organization, which provides robust medical and science-driven contribution to Benefit-Risk evaluation throughout product lifecycle to enable Novartis to provide impactful medicines to patients worldwide. Leads the day-to-day safety activities and provides guidance to assigned Medical Safety team members and mentee(s), as well as to the direct reports. Prepares objectives and evaluates related performance for the assigned team members. Provides expert safety input to the clinical development program, in particular for priority compounds; is an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT). Responsible for the review of PSURs together with QPPV office. Takes responsibility for MSRB presentations for his products/teams. Owns the safety strategy and documents it appropriately (e.g. dSPP, SSPT); leads the production of the medical safety deliverables (e.g. DSUR, PSUR, RMP) for the assigned products. Overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources. Initial development and ongoing maintenance of safety information in Core Data Sheet (core global labeling), including addressing safety issues optimally in all project/product labeling indications. Responses to inquiries from regulatory authorities or health care professionals on safety issues. Leads the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members. Prepares safety data for health authority review boards (together with the clinical and biostatistical functions). Attends Health Authority Meetings in person, as required. Prepares and presents safety issues to internal Novartis Boards and other meetings as required. Provides input to all relevant internal meetings with senior management (e.g., DevLT, TA LT, Medical Safety LT etc.) and other meetings as deemed necessary (e.g., GPT, SMT; GCT etc.) Initiates and maintains productive cross-functional Medical Safety collaborations with colleagues within PS&PV and those from other functions, e.g. Clinical Development and Medical Affairs, Regulatory Affairs, Medical Information, Biostatistics, Clinical Pharmacology, QA, BD&L and BR, as well as externally with expert panels and other scientific contacts. Education: Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable. Useful additional degrees: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent). Work Experience: • At least 7 years progressive experience in drug development in a major pharmaceutical company (of which 5 years in a global position), including 5 years in safety at a medical position. 5+ years clinical experience postdoctoral • Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information – to include NDA submission documents • Strong experience in leading cross-functional, multi- cultural teams • Strong experience with (safety or others) issue management • Strong experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications • Strong leadership skills including coaching, motivating, and directing, and fostering teamwork • Ability to develop and maintain effective working relationships with subordinates, superiors and peers • Strong experience with medical writing and delivering high quality documents such as RMPs, PSURs     Skills Desired Cross Functional Teams, Leadership, Medical Strategy, Multi Cultural Team Leadership, Process Safety Management, Regulatory Compliance, Safety Science, Strategy

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