Pharmacovigilance Associate

PSPSync; Deutschland; Remote; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company is seeking a Pharmacovigilance Associate in Germany to collect, verify, and report safety data related to adverse events. The role requires managing communications and conducting quality assurance to ensure compliance with regulatory standards. Candidates must hold a college diploma in a Life Science discipline and have at least 1-3 years of relevant experience. Multilingual skills in English and French are advantageous. This position demands meticulous attention to detail and a commitment to continuous learning.

Qualifikationen

• Minimum 1-3 years of experience in Medical Information, Clinical Research, or Pharmacovigilance.
• Familiarity with Pharmacovigilance industry guidelines and regulations.
• Strong verbal and written communication skills.

Aufgaben

• Collect and analyze adverse event reports and safety information.
• Ensure quality of safety event data and conduct regular quality reviews.
• Manage incoming communications and respond to inquiries.

Kenntnisse

Communication Skills

Attention to Detail

Multilingualism (English and French)

Medical Terminology Knowledge

Adaptability

Ausbildung

College diploma or degree in a Life Science discipline

Tools

Basic Computer Skills

Jobbeschreibung

PURPOSE

The Pharmacovigilance Associate is responsible for collecting, verifying, and reporting safety data related to adverse events, ensuring data accuracy and compliance with industry regulations. They support quality assurance, conduct risk analyses, manage communications, and maintain documentation to ensure the safety and integrity of pharmacovigilance activities.

PRIMARY DUTIES AND RESPONSIBILITIES

• Safety Reporting: Collect, verify, and analyze adverse event reports, product complaints, and other safety information from patients, clinics, and healthcare professionals, and submit them to pharmaceutical companies within tight deadlines.
• Data Entry: Enter safety event data into program-specific databases, ensuring accuracy and completeness.
• Quality Assurance: Ensure the quality of safety events data, conduct quality reviews, and identify areas for improvement.
• Communication: Manage incoming communications from multiple sources, respond to inquiries, and file documents according to Good Documentation Practices.
• Quality Investigations: Assist in conducting root cause analyses (RCAs) and executing corrective action and preventive action (CAPA) plans for quality discrepancies.
• Reconciliation: Conduct regular reconciliations with internal and external parties to ensure accuracy and compliance with agreements.
• Documentation: Maintain accurate and consistent patient records and related documents in accordance with Good Documentation Practices.

ADDITIONAL DUTIES AND RESPONSIBILITIES

• Be available for on-call duties as required.
• Perform other tasks and responsibilities as assigned periodically.
• Willing to work any 8‑hour shift between 8:00 AM and 8:00 PM, as needed.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS

• Educational Background: Minimum college diploma or degree in a Life Science discipline, such as biology, chemistry, or pharmacology, is strongly recommended.
• Professional Experience: A minimum of 1‑3 years of experience in Medical Information, Clinical Research, or Pharmacovigilance, or a related field within the pharmaceutical industry.
• Industry Knowledge: Familiarity with Pharmacovigilance industry guidelines, including Health Canada, US FDA, EMEA, and ICH regulations, is essential.
• Adaptability: Willingness to adapt to changing work environments and learn new skills as required.
• Multilingualism: Proficiency in both English and French is an asset, with the ability to communicate effectively with clients and stakeholders.
• Medical Terminology: Familiarity with medical terminology and coding systems is beneficial.
• Communication Skills: Strong verbal and written communication skills, with the ability to work effectively in a team environment.
• Technical Skills: Proficiency in basic computer skills, including software applications relevant to the industry.
• Ability to work effectively in a detail‑oriented environment.
• Demonstrates a commitment to continuous learning and professional development.
• Seeks opportunities for self‑improvement and growth in their role.
• Possesses a suitable independent/self‑directed work environment.