Pharmacovigilance Senior Specialist

hace 1 mes

Zaragoza, España PharmaLex GmbH A tiempo completo



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, market development, and effective product maintenance.

Pharmacovigilance Senior Specialist

Your Job

Professional leadership and provision of pharmaceutical expertise to clients in the field of pharmacovigilance:

Management of new pharmacovigilance projects, under the supervision of a Manager.

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.
  • Review and approve changes in literature searches or new strategies and QCs.
  • Periodic monitoring of the timelines and KPIs following the internal SOPs.

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.
  • Management of second level non-standard and customized MI enquiries including literature research, if necessary.

Your Profile

  • 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.
  • Sense of responsibility.
  • Knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance.
  • Familiarity with industry principles of pharmacovigilance.
  • Knowledge of pertinent medical or pharmaceutical concepts.
  • Detailed knowledge regarding project-related SOPs (internal and client-specific), global and local PharmaLex SOPs and pharmacovigilance-related SOPs.
  • Self-confidence and assertiveness.
  • Strategic, analytical and structured thinking.

We offer

  • Diverse tasks and challenging projects.
  • Very open, pleasant and collegial cooperation.
  • International company with various development and career opportunities.
  • Continuous development opportunities through exchange of knowledge and experience as well as further training courses.
  • Compatibility of work, family and private life.
  • Flexible working hours.
  • Possibility to work partly from home.

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 receiving your application documents stating your earliest possible starting date, any visa requirements, and salary expectations online.

Agencies only by prior agreement for the specific job opportunity.

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