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 (CSLs) Manager
- Project management activities
- Setup of projects
- Team design/training, set up of mailbox & folders for the project, management of accesses to different platforms, oversight of safety database configuration, investigate local requirements for Ethics Committees (ECs)/Investigators/National Competent Authorities (NCAs).
- Preparation of procedural documents (SOPs/Working Instructions (WIs)/ Working Practices (WPs)/templates as required)
- Participation in the preparation of Working Orders (WOs)/contracts with clients.
- Partners management (preparation of Pharmacovigilance Safety Agreements (PSAs), management for set-up in corresponding countries for PharmaLex (PLx) to be eligible to perform submissions on behalf of the sponsor & preparation of procedural documents 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).
- Oversight of assigned projects, assure that all procedures are in place and that all employees/third parties (if applicable) are trained and able to perform an accurate service on an ongoing basis
- Setup of projects
- Safety management - operations
- Consultancy on PV aspects for clinical safety
- Safety Management Plan (SMPs) preparation/update
- SAE/Pregnancy Forms preparation/update
- DSUR preparation/review
- Review of cases in safety database (QC)
- Other (oversight of signal activities related to clinical safety, coding activities).
- 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.
- Self-confidence and assertiveness.
- 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.
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.
For further information please don’t hesitate to contact us:
Agencies only by prior agreement for the specific job opportunity.