TRABAJO PHARMACOVIGILANCE BARCELONA, BARCELONA

You will be responsible for• support in the review of pharmacovigilance documentation (compliance and monitoring reports, etc... due to our constant growth, we are...

Auditing and compliance assessments:perform audits of software suppliers to verify adherence to annex 11, 21 cfr part 11, and other regulatory frameworks...

It is essential for maintaining the integrity of clinical data... effective communication and interpersonal skills... educating clinical staff on regulatory requirements...

Years of involvement in regulated activities (gcp/ pharmacovigilance (pv)), clinical development and/or qa positions... interrelationship of departments and business...

Lead the global medical affairs strategy and the integrated evidence generation plans for therapeutic areas, ensuring early engagement with external and internal...

Thorough knowledge and understanding of pharmacovigilance & safety deliverables, standards and processes at a global level; including pre and post launch experience...

You will be responsible for: leading risk management evaluation and resolution for assigned products and projects... alexion participates in e-verify...

pharmacovigilance... functional teams... provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues...