For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
ProPharma is seeking a dedicated professional to join our Regulatory Affairs and Pharmacovigilance team. In this role, you’ll prepare and manage regulatory applications, develop documentation for product placement, handle recalls, and ensure compliance with local and EU regulations. You’ll also monitor pharmacovigilance legislation, manage safety reports, conduct follow-ups, and support audits and inspections.
Regulatory Affairs
- Prepare and manage regulatory applications for marketing authorizations, variations, and renewals.
- Develop supporting documentation for product placement and maintenance.
- Handle product recalls and coordinate with partners and authorities.
- Assist with pricing and reimbursement regulatory activities.
- Review marketing materials for compliance with regulations.
- Monitor and communicate updates on local regulatory legislation.
- Provide consultancy and training for regulatory compliance.
Pharmacovigilance
- Monitor local and EU pharmacovigilance legislation.
- Manage Individual Case Safety Reports (ICSRs) and safety data processing.
- Conduct follow-ups with healthcare professionals and consumers.
- Perform expedited reporting to local authorities and Eudravigilance.
- Screen medical literature for safety information.
- Track and submit Periodic Safety Update Reports (PSURs).
- Handle medical information enquiries and product quality complaints.
- Support EU QPPV in maintaining Pharmacovigilance System Master File (PSMF).
- Participate in audits, inspections, and compliance monitoring.
Experience Requirements
- Two years of experience in the same/similar work in regulatory affairs.
- No previous experience in the pharmacovigilance field is required.
- Advanced theoretical and practical knowledge on local legislation necessary for the performance of regulatory activities in all countries where Clinres Farmacija operates.
- Experience with European and national regulatory submission and agency interactions.
- Experience leading successful sub-project and supporting client/stakeholders' relationship.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
