Career - Offer
Regulatory Affairs & Pharmacovigilance Manager
Type of job: full-time
Job Purpose:- To take responsibility for registration of products, renewals and variations in accordance with individual & business plan.
- To perform role of national responsible person for PV or to be responsible for communication with HA, respectively
- To establish/maintain PV system
- To take certain responsibilities in medical information management
- To take certain responsibilities in quality management.
- To take certain responsibilities in promotional material review.
- monitoring, following, reporting and implementing of all regulations and legislation requirements on the market
- Proactively provide strategic input and communicate critical topics in adequate and timely manner
- ensuring compliance with local & EU legislation/regulations, Company's SOPs and Partner companies' Policies & procedures
- creating/updating local SOPs
- ensure appropriate archiving of documentation and correspondence
- monitoring local legislation for new information related to the regulation and legislation and dissemination of relevant article to the appropriate employees
- overall responsibility for listed partner companies' products or therapeutic areas
- making appointments, organizing and preparing all required documentation for timely submissions for new products, renewals, and variations for products
- identifying and ordering documents needed for submissions
- amending of submissions when required by Regulatory Agency
- preparation and updating of SmPC/ PIL/labelling
- artwork correction
- co-operation with RAs as well as with defined contacts in partner companies
- performing a role of responsible person for pharmacovigilance (PV)
- establishing/maintaining of PV system
- creating/updating SOP on PV
- regular trainings of all employees on their role/obligation in PV system
- keeping training records
- timely reporting of adverse reactions to HA as per legal requirements
- timely reporting of local adverse reactions to partner companies as per business partner agreement if applicable
- keeping proper documentation on local adverse reactions received
- preparing PSUR schedules, ordering and submitting PSURs in a timely manner
- monitoring local legislation for new information related to the regulation and legislation and dissemination of relevant article to the appropriate employees
- monitoring, following, reporting and implementing of all regulations and legislation requirements on the market
- co-operation RAs as well as with defined contacts in partner companies
- take part in PV audits
- creating and updating SOP on promotional activities
- trainings of relevant employees on promotional activities rules/Codes of Conduct
- regulatory review and approval of promotional material
- advisory to PM/PS with the promotion material creation
- supporting SRs on their medical queries
- providing medical information to a clinician when requested
- providing Public Information Service
- providing service (giving of PIL) to blind and weak-eyed people when requested
- keeping appropriate records on medical queries
- preparation of short SmPCs
- interacting with partner companies/corporate medical director on specific information as needed
- check of promotional materials and approval
- preparing regulatory answers to quality issues
- dealing with quality complaints
- handling recalls
- take part in quality audits
- must understand and apply all company SOP's, policies and procedures
- take care of a good company reputation with his /hers positive attitude
- An opportunity to work for a successful international worldwide company
- An opportunity to broaden your knowledge and expertise in your field
- Continuous professional and personal development
- An attractive compensation package
V případě, že Vás nebudeme kontaktovat v průběhu následujících 14 dnů od odeslání Vašeho životopisu, jste nebyl/a vybrán do užšího kola výběrového řízení.
Zasláním Vašeho životopisu do společnosti Pharmaswiss, s.r.o., dáváte souhlas ke zpracování Vašich osobních dat a jejich uchování v personální databázi společnosti Pharmaswiss, s.r.o. za účelem získání zaměstnání pro Vaši osobu. Tento souhlas platí až do jeho odvolání.
Contact:
Ing. Simona Močubová
Updated: 7.5.2013
