At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world.
Janssen is a pharmaceutical company of Johnson & Johnson. Please visit http : / / www.janssen.com / for more information.
Local Safety Unit Head Location : Prague Full time unlimited contract Local Safety Unit Head ensures that the LOC product activities are managed in compliance with local regulations and company policies / procedures at a local, regional and global level and in accordance with any product vigilance agreements with third party business partners and have an appropriate system of pharmaco and consumer product vigilance and Risk Management in place to assure appropriate oversight for products within its responsibility.
Responsibilities : Key responsibility is to ensure that systems and processes are available for collection (initial and follow-
up), review, reporting and reconciliation of Adverse Events, Adverse Events combined with Product Quality Complaints and pregnancy reports obtained through the following sources : spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities and all other potential sources.
Your position will cover also :
Oversight of data generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential Adverse Events
Safety oversight of clinical projects conducted in the territory as applicable
Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs to ensure appropriate safety reporting to GMS or appropriate case management centre and Regulatory Affairs
Submission to Regulatory Affairs / Health Authorities
Plan and ensure timely submission of Aggregate Reports according to local regulations
Agreements / Contracts containing Pharmacovigilance Language
Inspection preparation & support
Collaborate & Support
Ensure implementation of Global and Cross-Pharma Procedural Documents as applicable and / or write, validate and implement the Local Implementation Memos (LIM) for Regional / International Pharmacovigilance Standard Operating Procedures / Working Practices and verify adherence
Ensure awareness of changes in regulations which may have an impact on pharmacovigilance activities and responsibilities.
Evaluate the impact on local processes and inform the appropriate global and regional groups (i.e. QPPV offices and Regional Cross-
Sector Safety Head) of any changes to local laws and regulations regarding pharmacovigilance
Case processing (spontaneous / solicited, clinical trials)
Oversight of activities generating patient data
Support / cooperation with external (Regulatory Authorities, pharma association, HCPs, PAGs) and internal stakeholders (global PV, regulatory, sales and marketing)
Audit / Inspection preparation
Contract review / Oversight to ensure safety obligations are defined and integrated as applicable
Evaluation of upcoming legislative changes and its impact on local processes
Safety training for company Employees.
Ready to travel between offices (Prague / Bratislava) and visiting stakeholders (60 % of time) to support business needs and oversight activities generating patient data.
University degree in medicine or pharmacy (or science if experienced in Pharmacovigilance and medical language).
By preference a minimum of 3+ years in a Pharmacovigilance responsibility role from multinational pharmaceutical company.
Proven expertise and experience in pharmaceutical regulations and R&D processes is preferred.
Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific / medical field.
Proven ability to organize workflow activities and manage multiple critical issues.
Awareness of and familiarity with industry principles of Pharmacovigilance, drug development and pharmacology. Knowledge of medical terminology.
Expert knowledge of Global, Regional and Local Pharmacovigilance Procedural Documents as applicable.
Computer literate with knowledge of Microsoft Office and relevant IT safety systems and / or ability to learn quickly.
Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.
Ability to establish and maintain open relationships within the organization and with authorities.
Strong organizational skills, attention to detail and accuracy
Open minded, positive, communicative, interested in developing others, a strong team player
Proven ability to manage projects as assigned and work unsupervised
Demonstrable knowledge of all local Pharmacovigilance requirements and of global aspects of drug safety.
Fluency in Czech / Slovak and English language is required.
We offer :
A challenging and interesting job in one of the biggest global healthcare companies
Extensive long-term opportunities for personal and professional development
Healthy and active work environment
Competitive salary based on experience and comprehensive benefits package