Global Pharmacovigilance Expert
hace 1 mes
We are a dynamic and growing company, offering exciting career opportunities. If you are looking for a challenging role with daily new experiences, then Pharmalex Gmbh is your perfect match. As a leading service company for the Pharmaceutical Industry globally, we specialize in all aspects of drugs and medical devices approval, market development, and effective product maintenance.
**Job Overview:**
- We are seeking an experienced Global Pharmacovigilance Expert to join our team.
**Job Description:**
The successful candidate will be responsible for:
- Providing professional leadership and pharmaceutical expertise to clients in the field of pharmacovigilance.
- PER Operational Support as:
- Local Literature Surveillance: Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases, and relevant information.
- Screening results of EMA Medical Literature Monitoring (MLM) and L2A.
- Local literature management through the local PVLit tool.
- ICSR Management:
- MedDRA and ATC coding of Adverse Drug Reactions and Adverse Events.
- Initial processing of incoming information.
- Translation of incoming information into English language, including QC.
- Data entry into PV database (SafetyEasy or client DB) and/or case tracking system, e.g., Excel.
- Initial ICSR assessment, if applicable.
- Evaluation of the need for expedited reporting to CAs/Partners of a client concerned, including reporting timelines.
- Cosmetovigilance:
- Handling all cosmetic products undesirable effects safety information according to the contract established with the Client.
- Medical devices:
- Handling all medical devices undesirable effects safety information according to the contract established with the Client.
- Medical Information:
- MI database registration and triage of MI enquiries, AE reports, PQCs, incidents, and non-medical enquiries received via email, fax, or phone.
- Management of verbal/written L1 MI enquiries according to approved standard reference documents, e.g., FAQs, SmPC/PIL, SRLs etc., in local language, including translations into English, if needed.
- Responding to the L1 MI enquirer, if applicable.
- Escalation of L2 MI enquiries to dedicated L2 Support.
- Submission of AE reports, PQCs, and incidents to dedicated destinations.
- Transfer of L0 non-medical enquiries to dedicated destinations.
- Preparation and/or maintenance of the FAQ document and Standard Response Letters (SRLs) including annual update in compliance with the most current Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and relevant regulatory documents.
- Management of second-level non-standard and customized MI enquiries, including literature research, if necessary.
**Required Skills and Qualifications:**
- Bachelor's degree in Life Science or demonstrable experience in Pharmacovigilance.
- Very good command of English.
- Autonomous, concentrated, and high-quality work.
- Ability to work in a team.
**Benefits:**
- A competitive salary range of €60,000 - €80,000 per annum, depending on experience.
- Opportunities for professional growth and development.
- A collaborative and dynamic work environment.
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