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.
(Senior) Manager Pharmacovigilance
The purpose of the position is to provide strategic support in pharmacovigilance (PV) system activities and work in PV projects as requested by the client.
- Support the PV audit service by performing PV audits as Co- or Lead-Auditor, PV SOP/GAP analyses, and audit/inspection readiness training;
- Support PV system set-up and maintenance, incl. provision of local responsible person for PV (LPPV) and/or EU-QPPV or respective deputy positions;
- Prepare and review PV quality management documents (e.g. SOPs, WIs);
- Create, implement and maintain Pharmacovigilance Agreements (PVAs) and System Master Files (PSMFs);
- Project management in the field of PV;
- Conduct initial and periodic PV training for the team and key clients;
- Represent the department and the company towards different authorities, associations and other organizations. Build, develop, and maintain working relationships with clients.
- Higher Degree in medical, natural sciences or pharmacy or other life-science-related fields;
- Ideally, 5 years of relevant previous experience and profound knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance;
- Knowledge of PV processes, the PV system, and QA/QM system structures;
- Ideally, knowledge of audit principles, procedures, and techniques;
- Previous experience in a PV service provider on different client projects or in a corporate PV department with exposure to relevant PV system management tasks (e.g. local safety officer/local QPPV, EU-QPPV or respective deputy positions of these) would be considered as a plus;
- English language fluency; German will be an advantage
- Proficiency in MS Office – with a strong focus on Excel, Outlook, and Word;
- Ability to adjust rapidly to new, unknown, challenging situations;
- Willingness to travel on business trips.
- Opportunity to conquer exciting and varied challenges alongside a talented team;
- Business interaction with nearly all branches of the company across 5 continents;
- A broad range of initiatives for personal development and professional training.
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.