A leading global biopharmaceutical company dedicated to improving the lives of individuals affected by orphan drugs and ultra rare diseases. Our commitment to excellence and innovation has driven us to expand our team and hire an Associate Director of Pharmacovigilance and GLP to join our dynamic organization.

They are looking for an Associate Director of Pharmacovigilance and GLP to lead and support our pharmacovigilance efforts and global product commercialization initiatives. The ideal candidate will have a strong background in pharmacovigilance, with extensive experience in GVP at both the EMEA and global levels. This is a unique opportunity to be a key player in a virtual organization and contribute to the development and launch of groundbreaking therapies.

Key Responsibilities:

• Lead pharmacovigilance activities at the EMEA and global levels, ensuring compliance with all regulatory requirements.
• Manage and collaborate with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) from a technical perspective.
• Utilize your experience in virtual start-ups to drive success in a virtual organization.
• Oversee and contribute to clinical trials, ensuring they meet all quality and regulatory standards.
• Collaborate cross-functionally with clinical, commercial, and quality teams, as well as regulatory affairs.
• Contribute to the development and execution of commercialization strategies for orphan drugs and ultra rare diseases.

Qualifications:

• 8-10 years of experience in Pharmacovigilance with a strong focus on Global Pharmacovigilance Practice (GVP).
• In-depth knowledge of regulatory requirements in the EMEA region and globally.
• Experience in managing CROs and CMOs, with a strong technical background.
• Virtual start-up experience is a plus.
• Strong clinical trials experience.

Benefits:

• Competitive compensation package.
• Career progression opportunities within a growing global biopharmaceutical company.
• The chance to make a significant impact in the field of orphan drugs and ultra rare diseases.
• Remote working options available in various European locations.

The Next Step for you:
Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1662 9120
Next Generation are specialists in Engineering, Data Science, Digital, Finance, IT Contract, IT Permanent, Life Sciences, Supply Chain, Procurement and Operations