Role Overview
As the designated safety lead for Greece and Cyprus, this position ensures alignment between local regulatory requirements and global patient safety standards. The role acts as the primary contact for safety-related matters within the affiliate, maintaining compliance with both national legislation and corporate pharmacovigilance policies.
Key Responsibilities
- Serves as the officially nominated Local Safety Responsible Person to national regulatory authorities
- Manages local safety operations, including budget oversight and resource planning
- Ensures timely collection, translation, and reporting of adverse events into the global safety database
- Collaborates with regional and global teams to implement regulatory updates and process improvements
- Oversees the development and maintenance of local safety procedures in accordance with company standards
- Coordinates training programs on adverse event reporting for customer-facing staff and business partners
- Supports the review and submission of periodic safety reports and adverse drug reaction data as required by law
- Participates in regulatory inspections and internal audits, ensuring continuous inspection readiness
- Contributes to risk management planning by adapting core documents to meet local regulatory expectations
- Facilitates safety communication efforts, including urgent alerts and letters to healthcare professionals
- Works with vendors and distributors to establish and maintain pharmacovigilance agreements
- Provides ongoing safety expertise to local crisis response teams
- Ensures 24-hour availability of safety reporting channels within the affiliate
- Reviews local medical literature for relevant safety signals
- Supports product complaint intake where applicable under local operating models
- Acts as liaison for health authority inspections within the safety domain
Collaboration and Development
This role actively engages with regional safety leads and global leadership to shape organizational development, capacity planning, and talent initiatives. It provides local insight into broader safety strategy and contributes to cross-functional projects that reflect regional needs.
Compliance and Expertise
The manager maintains up-to-date knowledge of national pharmacovigilance regulations and ensures internal processes reflect current requirements. They are responsible for updating safety SOPs, guiding contract arrangements, and verifying that all local stakeholders understand their reporting obligations.
