Are you interested in an independent and responsible position in a growing organisation with the opportunity to develop yourself? Then this might be your chance! Xendo is looking for an experienced Senior Consultant with Medical Safety & writing experience.
Xendo, a ProPharma Group company, is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare. Thanks to our multi-disciplinary, knowledge-driven approach, we deliver a broad palette of services to the life sciences industry, applying the right colour to projects we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations. ProPharma Group combined with Xendo has more than 1,000 professionals worldwide providing an unmatched variety of compliance related services including medical information, pharmacovigilance, clinical safety, regulatory affairs, and a continuously expanding range of compliance, quality assurance, validation, and consulting services; providing a full-colour spectrum.
The work is performed on a global level. Our office is located in Leiden where the QPPV & Medical Safety Science team is based, but it is an option to work from home as well.
The Medical Safety Science Team consists of a team of experts with very broad experience in analyzing and evaluating data and writing of required periodic reports. The main focus of the team is on report writing (DSURs, PSURs/PBRERs, (development) RMPs), risk and signal management, global literature assessment and providing consultancy or training for clients in the aforementioned areas, both in pre-approval and post-approval phase. The Senior Consultant reports to the Managing Consultant.
WHO WE ARE LOOKING FOR
This role is a challenging position for someone with at least 5 years’ experience within PV including 2-3 years of Pharmacovigilance medical writing experience; with a main focus on the EU. Preferably you also have work experience within a pharmaceutical company and/or regulatory authority in the area of pharmacovigilance.
The Senior Consultant is responsible for writing, reviewing and controlling the quality of safety reports such as DSURs, PSURs/PBRERs, PADERs, RMPs, Benefit-Risk Evaluation reports, signal detection reports, and other safety reports requested by clients. Other tasks are analyzing of safety data and other data relevant for safety reports. The Senior Consultant is involved in project management, communication with clients, writing of SOPs relevant for medical safety writing attending audits and inspections as required and providing client-specific training or training for colleagues as required. Other types of consultancy can also be part of the role, depending on the profile and experience of the consultant.
- PhD, MD or MSc University degree in Life Sciences (e.g. biology, biochemistry, physiology or chemistry) or related fields e.g. equivalent medical qualifications or nursing is preferred.
- Knowledge and/or understanding of PV, PV legislation and guidance, scientific and/or medical knowledge and knowledge of MedDRA.
- Extensive knowledge and experience in report writing;
- Proficiency or fluency in English, both written and verbal
- Experienced in working with MS Word and Excel
- Enthusiastic & self-starter.
- Analytical ability, organisation skills, problem-solving skills., technical writing skills, quality, result and client-oriented, flexibility in time and work/subjects
Please contact Paul Zantingh, Talent Acquisition Manager at +31 71 524 40 00 or by e-mail for additional information about job specifics.
- A dynamic and varied position in a fast-growing and professional organisation;
- Good terms of employment;
- Consultancy, Project Management, and Interim Management for a variety of clients;
- Great diversity in the content of the work
- An environment, which strives for high quality, continuous improvement, and knowledge sharing.