Lead/senior Safety Officer
hace 2 semanas
Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Lead/Senior Safety Officer who shares our vision of providing clinical research excellence.
Joining Pivotal as a Lead/Senior Safety Officer, means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.
**Why Pivotal**:
We are passionate and fully committed with medical science while using technology, to make a positive impact
We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong
**Description**:
Lead/Senior Safety Officer will give safety support for the projects with pharmacovigilance activities in order to meet the clients‘ needs and build new business for Pivotal. Support to clinical projects will ensure successful and timely completion of each project or study in accordance with Pivotal and/or sponsor´s SOPs, GCPs and national/international regulations.
**Lead/Senior Safety Officer will support**:
Development, tracking, reporting, and enhancing of the activities related to pharmacovigilance in clinical studies.
Maintenance of pharmacovigilance systems, including the safety database (ARGUS).
Data entry, review, and assessment of safety reports reports (including narrative writing) from clinical trial and post-marketing sources onto the safety database (ARGUS), in accordance with company SOPs and regulatory requirements.
MedDRA coding, including study coding reviews.
Preparation and submission of expedited reports to the regulatory authorities, including reporting to EudraVigilance, and periodic safety reporting to the regulatory authorities (e.g., IRAS and CTIS)
Safety events reconciliations.
Performing periodic quality controls of the safety database.
Creation and review of periodic safety reports such as DSURs and any other regulatory document as required.
**Required profile**:
University Science Degree (preferably life sciences or related) is advisable.
Between 5-7 years of Pharmaceutical Industry experience within Safety department is recommended.
Sound knowledge of GCPs/ICH and Spanish and International Regulations.
Intermediate level of spoken and written English.
Highly committed and ability to work under pressure.
Team player and good communications skills.
Empathy and ability to establish good relationships with others.
**Skills**:
Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
Strong written and verbal communication skills, attention to detail and ability to work in a fast
- pace environment
Ability to work autonomously
Ability to work in multiple projects
Fluency in English
Good knowledge of Office (Word, Excel and PowerPoint)
**What you can expect**:
Resources that promote your career growth
Leaders that support flexible work schedules
Trainings to help you build your therapeutic knowledge
Dynamic work environments that expose you to new experiences
**Commitment to Equal Opportunity**:
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