We are growing, grow with us!
Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? Then make PharmaLex your career choice!

PharmaLex is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting. We are specialized in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance activities. The success of our company resides in the expert knowledge and high motivation of our employees.

We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment.

So, if your career is much more than just a job for you but rather your passion, then come and join our successful team! In Sofia, we are looking for

Operational Lead (Pharmacovigilance) who will supports the Program Managers on the project set-up and implementation.

Specialist (Senior) Operational Lead (Pharmacovigilance)

Your Job

  •  Support finalization of the Work Order and Data Protection clauses
  • Preparation, circulation, review and finalization of the project-specific Working Practice (WP) and any other Client specific guidance
  • Engage PharmaLex entities, cross-VDC experts, consultants, and franchise / Alliance Partners into the Program
  • Oversees collection and archiving of CVs / JDs for individuals involved in the project and training compliance
  • Support developments of project-specific tracking systems
  • Actively informs Project Manager about potential risks/issues and discrepancies on target
  • Set-up team communication and information exchange platform
  • Oversees system onboarding of local teams (database, Call system, E-mail account and shared mailboxes, Sharepoints)
  • Provision training to local safety teams

Your Profile

  • Professional degree in Sciences or Economics
  • Extensive professional experience in the field of Pharmacovigilance
  • Expertise, experience and knowledge regarding relevant global and local legislative and non-legislative guidelines on Pharmacovigilance
  • Clear understanding of client needs
  • Ability to adapt flexibly to changing project conditions and open to change management processes
  • Capability of supervision, prioritisation and processing of parallel projects and tasks
  • Excellent team player
  • Complex problem solving, strong understanding of business
  • Very good written and spoken communication skills with internal and external customers, stakeholders, colleagues, and supervisors
  • Experienced user of the MS-office packages (excellent Excel knowledge), ERP-, project management and database systems
  • Very good command of English

We offer

  •  Opportunity to conquer exciting and varied challenges alongside a talented team
  • Flexible working hours (remote work possible)
  • Open and collaborative organizational culture with an emphasis on knowledge-sharing
  • Business interaction with nearly all branches of the company across 5 continents
  • A broad range of initiatives for personal development and professional training
  • The opportunity to grow in clinical safety field in the company

If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

Agencies only by prior agreement for the specific job opportunity.