Manager, Regulatory Affairs & Pharmacovigilance, Central EPM

Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.

As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live.

Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve.

We are a dynamic, fast-paced company, operating in over 35 countries across 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us!

The Manager, Regulatory Affairs & Pharmacovigilance for the Central Cluster (Romania, Moldova, Hungary, Czech Republic, Slovakia) will oversee regulatory and pharmacovigilance operations to ensure compliance with local and international regulatory requirements, support continuous improvement initiatives, and manage RA/PV activities while reporting directly to the Head of Regulatory Affairs & Pharmacovigilance, EPM, actively contributing to regional and EPM-wide regulatory and safety strategies.

Required Education and Experience

• Education / Knowledge

• University Degree in Pharmacy, Chemistry, Biology or other Life Sciences discipline

• Knowledge of the principles of RA and PV regulations in the relevant territories and global aspects of drug safety

• Computer literate

• Language skills: local language (fluent), English (fluent)

• A minimum of 6+ years pharmaceutical industry experience with at least 4-6+ years in Regulatory Affairs area

• A minimum of 2+ years pharmaceutical industry experience in a Pharmacovigilance role

• A minimum of 1 year experience as an auditor in Pharmacovigilance Audits

• Experience in a large innovative healthcare organization preferred

• Experience working with multinational staff organizations

Required Qualifications

• Proven ability to organize workflow activities and manage multiple critical issues

• Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external stakeholders

• Ability to establish and maintain open, professional, and trusting relationships within the organization and with authorities

• Works effectively in highly dynamic and changing environments, displays agility.