Medical Safety Established Medicines Group Lead Job In The Medicines Company In Hyderabad / Secunderabad, Telangana, India

Job DescriptionJob Description 2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it's growth, innovation, culture and how Sandoz impacts the lives of millions These will be careers with genuine impact! This is one such roleYour responsibilities include, but are not limited to: Efficiently and successfully manages the Sandoz Generics area within the BioPharma and Generics Medical Safety organization Enhances operational, scientific and clinical experience of Safety Leads through continuous training and coaching.

Leads the performance management process, including preparing safety objectives and evaluating and managing performance Leads the day-to-day safety activities of the Sandoz Generics Medical Safety team Oversees the assignment of activities within the team and ensures the timely delivery and appropriate quality oversight of Sandoz safety deliverables, including Medical Risk Assessments, PSURs and RMPs Responsible for safety issue management across the assigned portfolio, including the overall signal detection, monitoring, evaluation, interpretation, documentation and tracking and appropriate management of safety information.

In collaboration with the assigned team member, is responsible for responses to inquiries from regulatory authorities and internal stakeholders on safety issues Support in preparation of safety data for health authority review boards (together with the Sandoz clinical and biostatistical functions) Attends Health Authority meetings, as required.

Ensures safety information is communicated/escalated to HPS, Sandoz Management and/or EU Qualified Person in a timely fashion Coordinates and presents safety issues to internal Sandoz Boards and other meetings as required Provides relevant input for SMT and other governance boards as needed Initiates and maintains productive cross-functional Medical Safety collaborations with colleagues within other functions, Sandoz Generics (inc Clinical Development, Medical Affairs, Regulatory Affairs) and Sandoz Technical Operations.

Performs tasks assigned as per applicable procedures (eg, 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 (eg, GVP modules) requirements Works closely with other functions to ensure requirements for generics are represented in safety processes, and with Sandoz Generics functions to ensure PV activities are appropriately represented in Sandoz procedural documents.

Ensures implementation of such procedural documents in the area of responsibility Actively engages in process and system development to ensure the needs of the Sandoz Generics portfolio are included at the design and implementation phases Provides Medical Safety input for licensing activities, internal audits, regulatory authority inspections and for project /product recall activities Deputizes for Head Medical Safety (HPS) and perform delegated tasks as requiredDiversity & Inclusion / EEO Minimum Requirements .

Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required Specialty Board certification desirableUseful additional degrees: Post graduate degree in Pharmacology, Pharmaceutical Medicine Master of Public Health in Epidemiology (or equivalent) 4 years clinical experience postdoctoral At least 7 years progressive experience in medical safety in a major pharmaceutical company, including experience with a generics/ established product portfolio and ideally also originator drug development .

Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information Strong experience in leading multicultural teams Strong experience with (safety or others) issue management Strong experience in regulatory requirements, post approval PV methodolgies and product quality assessments 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 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 contribute to the development of departmental strategies Good project management and time management skills.

Strong knowledge of global regulatory requirements for safety reporting and labeling Previous people management experience preferredWhy Novartis766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's livesWe believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation That a diverse, equitable and inclusive environment inspires new ways of working We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.

And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges Because the greatest risk in life, is the risk of never trying!Imagine what you could do here at Novartis!Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

The Medicines Company is looking for .

The Medicines Company is looking for Any Graduate / Post Graduate profile candidates.