Company Description

FertiThera Labs is a European company dedicated to addressing multiple therapeutic categories, with a strong emphasis on Gastroenterology - Urology - Neurology and Longevity. We pride ourselves on producing innovative products through our own R&D department, ensuring that human and patient needs are always our top priority. As a reliable partner in the healthcare industry, we strive to improve patient outcomes with our state-of-the-art research and development capabilities.

Role Description

This role starts as a part-time and will soon develop to a full time hybrid role for a Regulatory Affairs and PV Officer, located in Kalamaria Thessaloniki, or in Athens (remote). The Regulatory Affairs and PV Officer will be managing and executing the full Regulatory Affairs life cycle across multiple simultaneous projects, maintain solid communication with EOF and establishing and maintaining local pharmacovigilance system and procedures covering all activities required by authorities.

Responsibilities:

Regulatory

• Overall responsibility for regulatory activities in cooperation with corporate functions for FertiThera Labs products and for partners’ products according to the business agreement.
• Development and implementation of regulatory strategic plans.
• Provide regulatory information/collaborate for development of the market access to align with products value proposition.
• Preparation of submission documents for approving drug codes and blue box (where applicable).
• When necessary, assist in the training of staff in regulatory policies or procedures.
• Maintain and update knowledge of regulations/policies/guidelines/initiatives.
• Ensure Health Professional communications, public communications, promotional materials and press releases are aligned to corporate regulatory standards and policies, and compliant with regulatory requirements.
• Create Regulatory SOPs

Pharmacovigilance

• Establishing and maintaining local pharmacovigilance system and procedures covering all activities required by regulations and safety agreements with partners.
• Collecting, reviewing, performing quality check and forwarding of Adverse Events and other safety information obtained through various sources to MAHs; tracking and archiving AEs; performing reconciliation activities and documentation. Managing the Adverse Events through Veeva Safety Vault
• Perform follow-up activities as applicable, track and document.
• Management of AEs related to Quality Complaints and Medical Information Queries.
• Submission of safety data to EOF according to local regulations.
• Submission of safety data to EOF according to local regulations.
• Create and manage Business Continuity Plans (e.g., inspection readiness, AE reporting coverage), ensure an effective system is in place for 24-h coverage
• Create and manage an appropriate PV and Risk Management SOP.
• Oversight/active involvement in implementation of RMP in collaboration with other departments, partners, etc.
• Conduct PV training programs to all staff and vendors and ensure awareness of pharma safety reporting.
• Ensure PV readiness, perform and take part in partners’ audits and regulatory inspections.

General

• Excellent organizational and time-management skills
• Detail-oriented with strong analytical and problem-solving abilities
• Effective communication and teamwork skills

Requirements:

• Bachelor's degree in Biology, Pharmacy, Life Sciences, or a related field
• Knowledge of the principles of RA and PV regulations of EOF
• Computer literate
• Language skills: local language (fluent), English (fluent)
• A minimum of 2+ years pharmaceutical industry experience with at least 2-years in a PV responsibility role
• 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.

Remuneration Package:

We offer a competitive and comprehensive package including:

• Base Salary (depending on experience)
• Annual Performance Bonus
• Company Car
• Health Insurance

Additional Benefits:

• Ongoing professional training and development opportunities
• Flexible working arrangements (hybrid office/remote)