REGULATORY AFFAIRS PROJECT MANAGER
OVERVIEW
Pharmexon Consulting is a dynamic Consultancy company for the pharmaceutical industry, specialized in offering full support for registration and approval of medicines in Europe. Our client base is worldwide and as we are rapidly growing, we seek to find people who would complement our teams and support us maintain and develop the current client base.
The Company is now facing an exciting time with further expansion of the business, leading to a number of opportunities arising in join our team. You will be based in our office in Prague (CR), working within an excellent environment in a friendly, professional team who will train and support you to meet the highest level of quality and client’s expectations. The successful candidate will receive full mentoring and training by ex-Health Agency level experts, continuing education in Regulatory matters and exposure to interesting Regulatory scenarios.
MAIN PURPOSE OF ROLE
Responsibilities will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Regulatory Affairs and Drug Development for pharmaceuticals for human use and/or Pharmacovigilance support. Any knowledge or experience in this area would be useful.
The RA manager will play an integral role in working with our clients and manage & support a variety of projects, interface with clients for new products and compliance-related issues. You will work closely with colleagues across the team and be a key contact for clients. Not only will the role develop your regulatory expertise and technical knowledge, it will also develop your client-facing skills.
KEY RESPONSIBILITIES
• Coordinating the entire projects with internal and external teams, making sure that timelines and projects are being delivered on time• Give clear instructions and complete details about projects to internal and external teams
• Becoming familiar with the EU regulation and additionally other regional regulations
• Client-facing responsibilities
SKILLS REQUIRED
• Relevant Degree in Science or related Discipline• Regulatory experience within pharmaceutical industry (desirable)
• Strong Project Management Skills and excellent attention to detail
• Proficiency with Project Management Software and document management
• Scientific knowledge sufficient to understand regulatory issues and affiliate scientific discussions
• Ability to work independently or as part of a team
• Good time planning skills
• Must be flexible and adaptable to changing project priorities and work assignments
• Excellent written and oral communication skills required, attention to detail and ability to handle multi-faceted projects at the same time a
• distinct advantage
COMMERCIAL OFFER
• Competetive salary• Salary negotiable and commensurate with experience
• Flexible working hours and/or part-time position available • Visa support for non-EU residents
BUSINESS DEVELOPMENT EXECUTIVE
OVERVIEW
Pharmexon Consulting is a dynamic Consultancy company for the pharmaceutical industry, specialized in offering full support for registration and approval of medicines in Europe. Our client base is worldwide and as we are rapidly growing, we seek to find people who would complement our teams and support us maintain and develop the current client base.
The Company is now facing an exciting time with further expansion of the business, leading to a number of opportunities arising in join our team. You will be based in our office in Prague (CR), working within an excellent environment in a friendly, professional team who will train and support you to meet the highest level of quality and client’s expectations. The successful candidate will receive full mentoring and training by ex-Health Agency level experts, continuing education in Regulatory matters and exposure to interesting Regulatory scenarios.
MAIN PURPOSE OF ROLE
The Business Development position liaises with our clients and our technical team and experts. We seek a highly motivated individual, with a proven track record working in the Pharmaceutical industry, who is able to secure and retain business through professional, consultative, proactive sales activities directed at decision-makers and decision influencers at existing and new clients.
It is required to have minimum one-year experience in business development with a solid commercial understanding and knowledge.
You will drive, demonstrate and support exceptional business solutions from business development and delivery of advanced capabilities and business solutions to both existing and potential clients.
KEY RESPONSIBILITIES
• Acting as a single point of contact between the company and its clients
• Managing day-to- day activities in the development and qualifying of business development opportunities
• Identifying new business opportunities and communicate feedback from customers
• Responding to request for information or proposals for clients
• Organizing and attending client meetings in person and following up with the actions steps from the meetings
• Meeting or exceeding business targets agreed for a period of time
• Understanding and identifying client’s needs and address it with the appropriate expertise Maintaining and developing relationships with existing and new customers
• Communication with clients. Creating detailed proposal documents (request for information, request for quotation, etc.), often as part of a formal bidding process
• Recording closed deals, sending signed hard copies to companies, entering all data into CRM
• Dealing with clients on the financial matters and, when required – outstanding invoices
• Representing Pharmexon at relevant industry events
SKILLS REQUIRED
• Highly fluent in English and any additional language such us German, French, Spanish (desirable)• High commercial compliance levels
• Previous experience in business development
• Ability to generate business by prospecting, setting up meetings and attending them in person
• Ability to negotiate terms of contracts
• Entrepreneurial mind-set and interest to work in a start-up environment
COMMERCIAL OFFER
• Competitive basic salary• Commissions package
• Visa support for non-EU residents
PHARMACOVIGILANCE MANAGER
ABOUT THE COMPANY
Pharmexon Consulting is a dynamic Consultancy company for the pharmaceutical industry. It specializes in offering full support for companies to develop, register, and maintain medicines on the market. Our clients are based worldwide and as we are rapidly growing, we seek to find people who would complement our teams and support us and also maintain and develop the current client base. The company is now facing an exciting time with further expansion of the business, leading to a number of opportunities arising to join our team. You would be based in our office in center of Prague (CR), working within an excellent environment in a friendly, professional team who will train and support you in order to meet the highest level of quality and client expectations.
SKILLS REQUIRED
• University graduate (Pharmacy, Veterinary Medicine, Biology)• Fluency in both written and spoken English.
• A good understanding of medical concepts and a confident user of English medical terminology.
• Easiness to communicate in English with foreign colleagues and business partners
• Adaptability to routine activities but also to finding fast answers and solutions to unexpected situations
• Willingness to quickly learn and develop in a multicultural team of highly skilled professional
• Good computer skills (Office-Excel, Word, PowerPoint; Outlook)
• Practical experience in Pharmacovigilance is an advantage
• Advanced knowledge of English
• Advanced knowledge of MS Word and MS Excel
• Independent problem solving and decision-making skills
• Process-oriented and critical thinking
• Excellent attention to detail and organizational skills
• Able to multitask
• Task-oriented approach
• Willing to do work-related reading outside of work
• Hard-working, self-reliant and responsible person
KEY RESPONSIBILITIES
• Report directly to EU QPPV• ICSRand AE management with notification through Eudravigilance and CIOMS form to the Cas
• Writing and Submission of PSURs / PBRERs and RMPs
• XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) management
• SOP, SDEA, and PSMF creation and review
• Signal Detection and Management
• Cooperation within the pharmacovigilance team
• Extensive Training
• Auditing
WE OFFER:
• An exciting and challenging job in an innovative, flexible, and growing company• A team of young, hard-working, open-minded and friendly colleagues
• Initiation and trainings in Pharmacovigilance field reflecting the latest European requirements
COMMERCIAL OFFER
• Salary is negotiable and commensurate with experience.• Flexible working hours.
• Meal vouchers / Contribution for meal