Pharmacovigilance Associate

C3i Solutions is a business process outsourcer specializing in global, high-touch consumer, patient and end user engagement. To ensure the expansion of our Operations Center in Sofia, we are now looking to recruit a:

Pharmacovigilance Associate fluent in English.

The Pharmacovigilance Associate will support multiple Clients and their teams in accordance with client specific performance milestones, obligations and commitments established by client or C3i Solutions Standard Operating Procedures (SOPs). Supports Pharmacovigilance Service Delivery: PV Directors, PV Systems, PV Managers and PV Operations.
Responsibilities:
• Assist in the management of key initiatives within PV management
• Assist Program Manager for the Hosted Only Programs
• Plan, attend and participate in client meetings
• In conjunction with PV Management, define, track and execute implementation timelines and strategies
• Track action items from client team and PV Staff meetings.
• Participate in SOP review as appropriate
• Participate in the Non Conformance process
• Assist with incident reports and outages
• Assist with the PV Notifications process
• Support PV team with client audit preparation
• Assist with the coordination of the updates to the CBD for PV Systems Clients
• Assist with status reports for PV Systems Clients
• Assist with the organization of the periodic review of PV Systems
• Responsible for the quality control (QC) of the documentation of the completed change control
- Ensure all documentation is filed as appropriate
• Responsible for the QC of the documentation of the validation packet
- Organization of associated documentation
- Ensure all documentation is filed as appropriate
• Assist with the maintenance of the PV contract list and expiration list
• Back Up Resource to the Service desk

Requirements:
• Bachelor’s Degree with strong communication and organizational skills
• Excellent English language skills – both verbal and written
• Strong MS Office - Excel, Word, Visio, and PowerPoint skills; Previous safety database experience highly desirable
• Previous experience in bio-pharmaceutical organizations or CROs is an advantage
• Ability to read and interpret documents such as safety rules, standard operating procedures (SOPs) or other job aids
• Ability to write routine correspondence, speak effectively and informatively, and respond to questions from customers, clients or associates by phone or in-person
• Excellent analytical ability and problem solving skills, including ability to trouble shoot issues and propose solutions
• Multitasking in a fast-paced environment and time management skills

If interested, apply via Jobs.bg - https://www.jobs.bg/job/4301123