Senior Pharmacovigilance Officer Geleen • Basic Pharma

Basic Pharma, a unique Dutch pharmaceutical company, is rapidly expanding, continually strengthening its organizational foundation, and advancing its specialization within the pharmaceutical industry. From product development, registration, production, and commercialization of (bio)pharmaceutical products to providing pharmaceutical services, Basic Pharma serves a diverse clientele ranging from startups to multinational corporations, both nationally and internationally.

Basic Pharma Manufacturing, manufactures various products such as nasal sprays, filled syringes, creams, and ointments. It also offers study medications and diverse services to third parties, including quality control and contract manufacturing.

Basic Pharma Technologies focuses on developing pharmaceutical products collaboratively with partners for its production organization and out-licenses them to customers. This unit now operates a biotech facility dedicated to product development and study medications.

Interdos specializes in providing consultancy services in the Regulatory Affairs, Pharmacovigilance, and Quality Management fields. Our expertise extends not only to internal support for Basic Pharma but also to external partnerships, ensuring seamless compliance and quality standards across the pharmaceutical landscape.

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.

The synergy of these activities under one roof positions Basic Pharma as a resilient and versatile player in the pharmaceutical industry. With approximately 250 professionals, Basic Pharma's ambitions are expanding, prompting the search for individuals committed to professionalism and customer satisfaction.

We are looking for

Senior Pharmacovigilance Officer

• 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 medical 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.

• Academic Degree in Life Sciences (for example, Biomedical Sciences or Health Sciences);
• Preferably 5-10 years of experience in performing pharmacovigilance activities;
• Preferably experience in writing pharmacovigilance documents such as: PSUR, Signal Detection, PSMF etc.;
• You preferably gained medical scientific knowledge;
• Knowledge of EU and national regulations/guidelines in the field of pharmacovigilance;
• 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.

• A challenging and responsible position within a dynamic, growing organization;
• Competitive salary and benefits package (including flexible working hours, hybrid work options, 28 vacation days, pension, etc.);
• Opportunities for professional development and growth;
• An inspiring and collegial work environment with an international character.

We do not appreciate acquisition in response to this vacancy.