Specialist Patient Safety
Job Summary
Job Description Summary
Join us the future is ours to shape!Job Description
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path unique opportunities will present themselves both professionally and personally. Join us the future is ours to shape!
Your Key Responsibilities
Support the Senior Manager Patient Safety in the coordination and execution of patient safety activities within the Sandoz affiliate.
Support engagement with the affiliate organization to promote understanding of the pharmacovigilance system and adherence to local safety requirements including implementation and tracking of local Risk Management Plan (RMP) commitments under guidance from the Senior Manager.
Support the effective accurate and timely flow of safetyrelevant information within the affiliate and between local business partners regional hubs and thirdparty vendors escalating issues as appropriate.
Maintain awareness of the safety profiles of Sandoz products and support the Senior Manager by providing patient safety input for marketed and investigational products in line with established procedures.
Participate in the oversight of pharmacovigilance activities including those outsourced to thirdparty vendors on behalf of the affiliate
Assist in the maintenance of the UK Pharmacovigilance System Master File (PSMF) in accordance with local regulatory requirements
Support the development of patient safety training materials and participate in local Business Continuity Plan (BCP) testing
Support the maintenance of the local Quality Management System (QMS) including:
Training and competency management
Records document management and archiving
Compliance management
Local regulatory intelligence
Audit and inspection readiness activities
Deputy Responsibilities
Act as Deputy for the Senior Manager Patient Safety carrying out delegated responsibilities and providing operational cover.
What Youll Bring to the Role
Essential Requirements
Education
Health Care Sciences professional (e.g. Medical Doctor Nurse Pharmacist) or equivalent education training and relevant experience
Certified proficiency in written and spoken English
The role requires the candidate to be based in the UK
Experience and Skills
At least 3 years experience in drug safety pharmacovigilance or a related pharmaceutical environment
Sound knowledge of local and international regulations including applicable pharmacovigilance requirements
Strong knowledge of pharmacological and medical terminology
Excellent communication and interpersonal skills with the ability to collaborate effectively in crossfunctional and multicultural teams
Quality and resultsoriented with strong attention to detail and compliance
Proven project management skills including the ability to manage multiple priorities and timelines
At least 2 years of experience in a Patient Safety Specialist role or similar (preferred)
Youll receive:
Competitive salary Annual bonus Pension scheme Health insurance 24 days annual leave Flexible working arrangements Employee recognition scheme learning and development opportunities.
Why Sandoz
Sandoz is the global leader in Biosimilar and Generic medicines a segment of the healthcare industry that delivers 80% of the worlds medicines at 30% of the cost touching the lives of more than 1 billion people across 100 countries! While we are proud of our achievements we have an ambition to do more so that everyone can achieve the basic humanrightof good health.
With investments in new development capabilities production sites new acquisitions and partnerships wehave the opportunity toshape the future of Sandoz and help even more people gain access to low-cost high-quality medicines sustainably.
Our momentum 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 careers where diversity of thought is welcomed and where personal growth is supported!
Join us help us make healthcare fairer and faster.
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.
#Sandoz
Skills Desired
PharmacovigilanceRequired Experience:
IC