Pharmacovigilance Expert for Global Pharmaceutical Industry
hace 2 semanas
We are a dynamic and growing company in the pharmaceutical industry. Our mission is to provide expert services to our clients around the world. If you are looking for a challenging and rewarding career, then this may be the opportunity for you.
Our company, Pharmalex Gmbh, is a leading service provider for the global pharmaceutical industry. We specialize in all aspects of drug approval, market development, and product maintenance. As a Pharmacovigilance Senior Specialist, you will play a key role in our team and be responsible for providing professional leadership and pharmacological expertise to our clients.
Your Job
Professional Responsibilities:
- Management of new pharmacovigilance projects under the supervision of a Manager
- 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
- Review and approve changes in literature searches or new strategies and QCs
- Periodic monitoring of the timelines and KPIs following the internal SOPs
Key Tasks:
- ICSR Management: MedDRA and ATC coding of Adverse Drug Reactions and Adverse Events
- Initial processing of incoming information
- If applicable, 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
- Preparation of standard reporting forms (i.E.: CIOMS I, Medwatch forms and XML files)
- Preparation and sending of FU request
- Submission of ICSRs to CAs and Partners of a client
- Case completion/documentation
- Periodic monitoring of the timelines and KPIs following the internal SOPs
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
Salary: The estimated salary for this position is $120,000 per year, based on industry standards and location. This figure may vary depending on factors such as experience and qualifications.
This is an exciting opportunity for a highly skilled and motivated individual to join our team and contribute to the success of our company. If you have the necessary skills and qualifications, please apply.
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