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.
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.
Good knowledge of current PC-applications.
Highly committed and ability to work under pressure.
Team player and good communications skills.
Empathy and ability to establish good relationships with others.
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.
Commitment to Equal Opportunity: At Pivotal, we believe that diversity and inclusion are essential to the success of our team.
We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.