Country Patient Safety Manager CZ/SVK
Novartis
- Praha
- Trvalý pracovní poměr
- Plný úvazek
- Build 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 Patient Safety HUB/ Associated Director Patient Safety HUB and 3rd party vendors
- Management of Adverse Events: Ensure the local management of adverse event information, with the following aspects (In collaboration with 3rd party vendor routine operational activities may be partially or completely outsourced)
- Product Complaints management: Maintain awareness of product complaints received in the affiliate, ensure exchange and reconciliation of product complaints associated with adverse events
- Management of Local Literature: In collaboration with 3rd party vendor, identify the local journals required for screening, maintain overview on search results specifically any potential safety signals or aspects relating to benefit/risk
- Health Authority Requests (and other externally generated signals): In collaboration 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
- Risk Management: Cooperation and oversight of the implementation of local RMP commitments and effectiveness checks. Ensure the country oversight of implementation of Post Authorization Safety Studies and additional Risk Minimization Measures at local level
- QMS and supporting processes: Ensure the local Pharmacovigilance requirements are met. Identify 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
- Audits and Inspections: In cooperation with the 3rd party vendor, QA and other applicable groups, maintain audit/inspection readiness with the support of regional hubs and 3rd party vendor and manage any local Pharmacovigilance audit/inspection. Contribute as Pharmacovigilance SME, in other internal Sandoz audits and/or third-party audits, as applicable
- Sandoz Patient Safety Governance: 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
- Affiliate Governance: participate or maintain awareness of key governance meetings in the affiliate to stay informed of important developments in the affiliate that may have an impact on the conduct of safety activities
- External governance: Build relevant external interfaces with local distributors, license partners, vendors to collaborate on day-to-day matters and oversee the adherence to safety relevant obligations of contracts and PV agreements
- External relationships: build relationships with health authorities, industry as-sociations, healthcare professionals, patients and caretakers etc..
- 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
- Certified level of written and spoken English, fluent in Czech
- Extensive knowledge of regional and local requirements relating to PV. Ability to solve complex regulatory issues and requirements.
- Working knowledge of PV-processes, covering compliance, databases, procedures, QA, training. Proven ability to critically evaluate and integrate data from a broad range of areas/domains. 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
- Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary
- Risk Life Insurance
- 5-week holiday per year (1 week above the Labor Law requirement)
- Cafeteria employee benefit program - choice of benefits from Benefit Plus CZ in the amount of 12,000 CZK per year
- Public Transportation Allowance
- Meal vouchers in amount of 116 CZK for each working day (full tax covered by company)
- Multisport Card
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!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: https://talentnetwork.novartis.com/sandoztalentpool#sandozFunctional AreaResearch & DevelopmentDivisionSANDOZBusiness UnitNON-NVS TSA COMMERCIAL OPS EUROPE SZEmployment TypeRegularCommitment to Diversity & Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.Shift WorkNoEarly TalentNo