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 Specialist Pharmacovigilance
- Perform Local PV activities (local literature search, case processing, translations)
- Support PV system set-up and maintenance
- Prepare and review QA documents such as Working Instructions, SOPs, Working Procedures, Templates, etc.
- Participate in different Project management within the filed of PV
- Support the PV service coordination by:
- Creating Proposals and RfP's
- Preparing and reviewing MSA/WO/WP (contract management)
- Setting-up and provide maintenance support for partners/consultants in PLx systems
- Supporting identification of new partners
- Assisting in vendor/partner qualification/ re-qualification.
- Assist in establishing and maintaining Pharmacovigilance System Master Files (PSMF) and Risk Management Plans (RMP)
- Preform global and local literature reviews and provide medical review and information (if applicable)
- B.Sc. or M.Sc. Degree in medicine, natural sciences or pharmacy
- At least one year of experience in pharmacovigilance and related aspects
- Detailed knowledge of the applicable legislation (e.g. GVP, AMG)
- C1 level of English both written and spoken
- Ideally, a good command German language
- Proficiency in MS Office – with a strong focus on Excel, Outlook, and Word.
- Opportunity to conquer exciting and varied challenges alongside a talented team
- Option for flexible working hours
- 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.
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.