Clinical Safety Lead - Manager

We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

Clinical Safety Lead - Manager

Your Job

• Project management activities
• Setup of projects
• Team design/training, mailbox & folder for project creation, management of accesses to different platforms, oversight of safety database configuration (liaison with PVIT team), investigate local requirements for ECs/Investigators/NCAs.
• Preparation of procedural documents (SOPs/WIs/WPs/templates as required)
• Participation in the preparation of WOs/contracts with clients.
• Partners management (preparation of PSAs, management for set-up in corresponding countries for PLx to be eligible to perform submissions on behalf of the sponsor & preparation of procedural docs with partners describing the processes to be followed).
• Communication with client (leading functional meetings)
• Communication with other affiliates and/or with other teams involved.
• Support in QA activities for every project (training management, liaise with QA department, preparation of CAPAs, participation in Audits/inspections).

Your Profile

• Successful completion of a Bachelor’s degree in medical, natural sciences or pharmacy-related field or Degree in Medicine
• Good knowledge of clinical trial PV legislation (at least in EU) and in Good Clinical Practices
• Extensive professional experience in the field of Pharmacovigilance.
• Experience in project management and in writing of PV procedural documents (SOPs, SMPs, other)
• Minimum of 2 years of experience in the clinical safety area.
• Experience in case management activities (including narrative writing) and in the management of information in safety databases.
• Previous experience in aggregate reporting writing is preferred.
• Organizational skills, ability to multi-task. Ability to assimilate and analyse information rapidly.
• Strategic, analytical and structured thinking.
• Ability to identify and offer solutions to problems in a pragmatic way.
• Flexibility and adaptability to adjust rapidly to new, unknown, challenging situations.
• Fluent written and spoken English skills.
• Excellent written and verbal communication skills.

Agencies only by prior agreement for the specific job opportunity.