Job Description Summary
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our 'new' Sandoz.
As Patient Safety Manager, you will lead pharmacovigilance activities in the Sandoz affiliate across Malaysia, Singapore, Brunei, Philippines and South Korea in the context of the Sandoz Pharmacovigilance System, patient safety operating model, and associated quality system. You'll ensure that local safety procedures are comprehensive, effective, compliant and well embedded in the cross-functional and global-regional-local environment. Job Description Your Key Responsibilities: Your responsibilities include, but not limited to:
Building strong relationships with relevant functions in the affiliate organization (including but not limited to regulatory affairs, medical affairs, quality assurance, marketing and sales, clinical development and others), in collaboration with the Director/ Associate Director of the Patient Safety HUB and 3rd party vendors.
As defined by local regulations act as the Local Qualified Person for Pharmacovigilance in the country(ies), you'll act as the single point of contact with the Local Health Authority.
Ensures the local management of adverse event information, with the following aspects (In collaboration with 3rd party vendor where routine operational activities may be partially or completely outsourced):
Identification of sources of adverse event information, from any source in the country
Maintaining oversight on case content and reporting
Maintain awareness of product complaints received in the affiliate, ensure exchange and reconciliation of product complaints associated with adverse events and more.
Collaborates with 3rd party vendor, Regulatory Affairs (RA) and other functions, ensure processes are in place to answer fully and promptly any safety related requests from Local Health Authorities and maintains oversight on results of the signal management process, including any relevant subsequent actions, such as safety variations, ARMM, or ad hoc safety measures.
Ensures the local Pharmacovigilance requirements are met. This is not limited to identifying specific requirements that may not be covered by global procedures and communicate to the Sandoz regional hub. Where required, implement local procedures to supplement PS global procedures and to ensure compliance national requirements.
Ensure that all local internal and external stakeholders are adequately trained from pharmacovigilance obligations.
Collect and share relevant metrics for local business volumes and performance. Participate in governance meetings at regional and global level to have oversight on the performance of the PV system.
Promote innovation to improve processes and deliverable quality and take every opportunity to use the projects for teaching and developing team members.
What you'll bring to the role: Essential Requirements
Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience.
Minimum 5 years' experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry
Minimum 2-3 years of demonstrated leadership and accomplishment in all aspects of patient safety in a local/matrix environment in the pharmaceutical industry. This includes extensive knowledge of regional and local requirements relating to PV (PV processes, compliance, databases, QA, training, audits and inspections). Ability to solve complex regulatory issues and requirements.
Ability to effectively communicate with different stakeholders.
Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.
Experienced leader in a matrix organization, including ability to influence and provide guidance and direction to team members.
Demonstrated ability for innovative and big picture thinking.
Strong planning, negotiation, organizational and interpersonal skills.
Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion : We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)
#Sandoz Skills Desired
Clinical Trial, Databases, Employee Training, Pharmacovigilance, Project Management, Reporting, Safety Science, Team Management #J-18808-Ljbffr
