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Sandoz is Hiring a Director QPPV Office Near Home, KS
Your Key ResponsibilitiesYour responsibilities include, but not limited to:
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 & InclusionWe 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
- Support EU-QPPV for Sandoz to fulfil role requirements as indicated in the Guidelines on Good Pharmacovigilance (PV) Practice (GVP), through performing the below tasks and reporting issues and aligning actions to EU-QPPV
- Assess impact of new PV-related legislation with focus on EU/EEA and provide sup- port to other functions on strategic impact of any changes.
- Oversight of safety profiles and any emerging safety concerns in relation to medicinal products for which Sandoz holds marketing authorizations.
- Collaborate as required in audits / inspections and response processes.
- Oversight of the quality management system for the PV system, in collaboration with the QA function.
- Support talent / career development of team members within and outside QPPV function, through involvement and education.
- To establish and maintain a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the Marketing Authorization Holders (MAHs), and its medical representatives, is collected and collated in order to be accessible at least at one point within the European Union/European Economic Area (EU/EEA).
- To ensure a complete oversight of the structure and performance of the Sandoz global PV system, in order to promote, maintain and improve compliance covering the following aspects:
- Quality control and quality assurance/audit plan and audit reports;
- Global working procedures and databases operations.
- Expediting ICSR reporting and aggregate reports (PSURs, DSURs and RMPs) in relation to quality, focusing on accuracy, complete- ness and timeliness.
- Training of personnel in relation to PV and Risk Management
- Licensing agreements.
- Post-authorisation safety studies, with appropriate input (including at CMO & PS Leadership Meetings) as required.
- To ensure timely and quality preparation (together with PV, Regulatory Affairs (RA) and Medical Safety) the appropriate medical input to PV reports including:
- Individual Case Safety Reports (ICSRs)
- Periodic Safety Update Reports (PSURs)
- Company-sponsored post-authorization safety studies (PASS)
- Risk Management Plans (RMPs)
- for Competent Authorities of the Member States where the medicinal product is authorized, and for the UK National Competent Authority.
- To ensure (through supervision), that the post-authorisation commitments are fulfilled completely together with Regulatory Affairs, Medical Safety and Safety Sciences, with appropriate medical input.
- To ensure that any PV request from the EU/EEA Competent Authorities for the provision of additional information necessary for the evaluation of the benefits and the risks afforded by a medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions of the medicinal product concerned.
- To conduct continuous overall PV evaluation during the post-authorization period. This includes oversight of PV operations in Europe/EEA and non-EU/EEA countries, with QPPV requirements together with PV, Safety Operations & Compliance, Medical Safety & Risk Management, Regional and the Country Patient Safety Head network in order to ensure complete oversight of the structure and performance in country systems and across Patient Safety.
- To collaborate as required in audits/inspections and response processes in the EU/EEA region and non-EU/EEA countries with local QPPV requirements together with Sandoz Global Development QA and Regional Pharmacovigilance/Quality Head
- To assess the impact of new pharmacovigilance related legislation with focus on EU/EEA and provide strategic support to Sandoz Global Development on EU/EEA pharmacovigilance matters on strategic impact of any changes.
- Ensure complete awareness of emerging safety concerns and safety profiles relating to medicinal products for which Sandoz MAHs hold authorisations together, with appropriate medical input into urgent EU/EEA/ regulatory actions and information flow to EU-QPPV Country Patient Safety Responsible (CPSR) network, as re- quired (together with the Heads of Patient Safety).
- To ensure access to all information sources maintained to oversee structure and performance of PV systems across all countries where Sandoz holds marketing authorizations.
- To ensure understanding/awareness of QPPV role maintained at Global and country level through presentations at Regional/Global meetings
- MD, PhD or nursing/pharmacy degree
- Management training and experience
- High level of expertise in PV, including aspects of medical safety, gained in a European environment (minimum of 10 years), including preferably experience in a major EU/EEA country or the UK
- Excellent knowledge of European (regional and national, including the UK) regulatory requirements relating to PV
- PV systems experience (covering compliance, databases, procedures, QA, training)
- Management experience at managing drug safety or RA team (line or functional management)
- Experience in the area of audits/inspections
- Ability to effectively communicate and influence at all levels
- Excellent knowledge of English, both oral and written
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 & InclusionWe 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
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$130k-171k (estimate)
POST DATE
05/31/2024
EXPIRATION DATE
06/28/2024
WEBSITE
sandoz.uk.com
HEADQUARTERS
CAMBERLEY
SIZE
100 - 200
FOUNDED
1981
CEO
CHINMAY UMESH BHATT
REVENUE
$50M - $200M
INDUSTRY
Pharmaceutical
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