We are looking for a (Junior) PV 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:

We encourage (recently) graduated students to apply for this role. If you are highly motivated and proactive, open to challenges and want to learn in a short period of time with the help of a highly experienced team, we recommend you to apply.

• 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, professional attitude.

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.