Our company

Basic Pharma is an unique Dutch pharmaceutical company that is growing at lightning speed, is constantly building its organization and is constantly specializing and developing. The company focuses on the full breadth of the pharmaceutical industry: from product development, registration, production and commercialization of (bio) pharmaceutical products to pharmaceutical services. Basic Pharma has an ever-increasing circle of national and international customers, from start-ups to multinationals.

The production organization Basic Pharma Manufacturing makes products such as nasal sprays, filled syringes, creams and ointments. In addition, it also supplies clinical study medications and offers various services to third parties, such as quality control and contract manufacturing.

Basic Pharma Technologies is responsible for the development of new products and (manufacturing)processes in a project management office. This is accomplished by a dedicated multidisciplinary team of pharmaceutical experts. In addition, this business unit has a biotech facility.

Finally, Interdos the daughter company of Basic Pharma has built up a solid track record with advisory and consultancy services in the field of Regulatory, Pharmacovigilance and Quality.

The availability and combination of all activities under one roof makes Basic Pharma a strong and versatile player within the pharmaceutical industry. Currently there are approximately 200 employees. Basic Pharma's ambitions go further and that is why we are looking for employees who are committed, who consider professionalism of paramount importance and who put the customer first. Does this appeal to you? Then the vacancy below might be something for you!

For Interdos Pharma BV we are looking for a

(Junior) Pharmacovigilance Officer

Interdos Pharma BV is a pharmaceutical company as well as an independent CRO providing services for human medicinal products and medical devices (CE products).

The clients of Interdos Pharma BV are mainly small and medium-size pharmaceutical companies worldwide, who often have a pharmacovigilance (PV) system under development or are undergoing major changes with (initial) marketing authorization applications.

The team of Interdos possesses in-depth knowledge and extensive experience in a comprehensive range of professional services: regulatory support,  PV services and quality assurance activities.

Tasks and responsibilities:

• Timely and correct execution of the assignments according to defined timelines with highly qualified output;
• Independently performing pharmacovigilance activities in accordance with statutory requirements that are based on established procedures;
• Electronic reporting of the side effects of registered products (ICSRs) and ensuring their adequate documentation;
• Screening local and world-wide literature;
• Preparation of Periodic Safety Update Reports (PSURs) and submitting them to the competent authorities;
• Ensuring timely delivery of good quality data and documents for various reports;
• Carrying out Signal Management process;
• Compiling Product Dictionaries in the context of EVWEB registration;       
• Supporting development of Risk Management Plans;
• Drafting of Pharmacovigilance System Master Files (PSMF) and its Annexes;
• Assisting in development of safety agreements (SDEAs) and their maintenance;
• Writing Standard Operating Procedures (SOPs) and their maintenance;
• Communicating with internal/external companies/business partners who have outsourced pharmacovigilance to Interdos Pharma;
• Reconciliation of safety data with business partners.

Knowledge/experience:

• Preferably 2-3 years of experience in performing pharmacovigilance activities;
• You preferably gained medical scientific knowledge;
• Knowledge of EU and national regulations/guidelines in the field of pharmacovigilance;
• Preferably, knowledge of the electronic submission of adverse event reports;
• Knowledge of working with Word and Excel;
• Good mastery of the Dutch and English language in word and writing;
• Accurate, planning and organizational skills, result-oriented, eye for details, professional attitude.

Education:

The candidate we are looking for has an Academic Degree in Life Sciences (for example, Biomedical Sciences or Health Sciences).

We encourage our employees in their development by offering (internal) courses and training.

What we offer:

• A challenging function within a highly qualified team with room for your own input;
• Competitive compensation with good secondary employment conditions, including flexible working;
• Dynamic and inspiring working environment in an ambitious, growing organization.

Acquisition in response to this vacancy is not appreciated.