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 About the Role 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 Enhances scientific and clinical experience of Medical Safety physicians scientists through continuous training and coaching Prepares safety objectives and evaluates and manages performance of the Medical Safety associates within the TA DU Identifies talents and high potential associates and is able to defend and discuss in front of leadership team Together with associates identifies carrier development opportunities and support associates in the carrier path 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 Mentors junior PS PV personnel Proactively engages in the development of competencies across the Medical Safety Function 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 When necessary takes responsibility for the strategic reviews of documents for ISRC and C-ISRC Responsible for the review of PSURs together with QPPV office Takes responsibility for MSRB presentations for his products teams Responsible for regular review and updates of key internal Novartis safety documents either as individual contributor or as manager of the Safety Team Ensures that all project-related safety documents are consistent in safety messages 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 Responsibilities whether as individual contributor or Team Lead depending on the team size complexity and project needs include a 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 Ensures that the team appropriately and timely reviews all medical safety data from various sources e g pre-clinical clinical trial data post-marketing literature throughout the development and post-approval process b Documentation tracking record keeping of medical safety activities for the assigned compounds c 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 d 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 e Responses to legal queries and Country Organization CO requests involving safety issues Provides integrated safety input into all regulatory documents required during active development Ensures safety information is communicated escalated to senior management in a timely fashion Facilitates involvement of external experts e g authors of white papers members of trial- specific data safety monitoring boards ad-hoc support for HA meetings etc 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 Provides expert medical input to trial and project level Drug Safety Monitoring Board Data Monitoring Committee and Safety Adjudication Committee activities for assigned projects products as required Performs tasks assigned as per applicable procedures e g GOPs SOPs WIs assigned to the role Keeps working instructions SOPs GOPs for the area of responsibility up to date with internal e g QMs and external e g GVP modules requirements provides input to such procedural documents of other functions and ensures implementation of such procedural documents in the area of responsibility Provides support as needed for licensing activities regulatory authority inspections and for project product recall activities Deputizes for Head Patient Safety HPS as required Key performance indicators Timeliness and quality of safety analysis interpretations presentations and communication in all the assigned programs Strategic input and guidance in the assigned programs Compliance with internal SOPs WPs and external regulations 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 Solid experience in drug development clinical trial methodology regulatory requirements scientific methodology statistics and writing of publications Strong leadership skills including coaching inspiring and directing and fostering teamwork Ability to develop and maintain effective working relationships with subordinates superiors and peers Strong negotiation and conflict management skills Excellent written and verbal communication skills Strong experience with medical writing and delivering high quality documents such as RMPs PSURs Proven administrative skills including the ability to set and achieve goals and develop departmental strategies Good project management and time management skills required Robust knowledge of global regulatory requirements for safety reporting and labeling Previous people management experience preferred Why Novartis Helping people with disease and their families takes more than innovative science It takes a community of smart passionate people like you Collaborating supporting and inspiring each other Combining to achieve breakthroughs that change patients lives Ready to create a brighter future together https www novartis com about strategy people-and-culture Join our Novartis Network Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up https talentnetwork novartis com network Perks and Rewards Read our handbook to learn about all the ways we ll help you thrive personally and professionally https www novartis com careers benefits-rewards Division Development Business Unit Development Location India Site Hyderabad Office Company Legal Entity IN10 FCRS IN010 Novartis Healthcare Private Limited Functional Area Research Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to email protected and let us know the nature of your request and your contact information Please include the job requisition number in your message Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve

📌 Senior Global Program Safety Team Lead (Telangana)
🏢 Novartis
📍 Telangana