Regulatory Affairs Specialist for Pharmacovigilance

1 semana atrás


Lisboa, Lisboa, Portugal Primevigilance Tempo inteiro

About the Company

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We are PrimeVigilance, a leading pharmacovigilance service provider with global reach and expertise. Our team of professionals is dedicated to delivering high-quality support to pharmaceutical and biotechnology partners across various therapy areas.

At PrimeVigilance, we prioritize diversity, equity, and inclusion by creating an equal opportunities workplace where people from all cultural backgrounds can contribute and grow. We value teamwork, collaboration, and open communication in achieving our goals.

Job Summary

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We are seeking a highly skilled Regulatory Affairs Specialist for Pharmacovigilance to join our team. In this role, you will be responsible for reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. You will also act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance in evaluating safety issues.

You will review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy, and Risk Management Plans. Additionally, you will cooperate in the preparation of responses to regulatory authority requests and participate in signal detection activities, including meetings and writing signal detection reports if applicable.

Key Responsibilities

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  • Review and approve ICSR and SAE reports for medical/causality assessment">
  • Act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance in evaluating safety issues">
  • Review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy, and Risk Management Plans">
  • Cooperate in the preparation of responses to regulatory authority requests">
  • Participate in signal detection activities, including meetings and writing signal detection reports if applicable">

Requirements

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To be successful in this role, you should have:

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  • A medical degree as a physician">
  • Previous experience in pharmacovigilance">
  • Ability to review different aggregate report types, including PBRERs and DSURs">
  • Expertise in signal detection activities">
  • Excellent interpersonal and communication skills">
  • Ability to plan, organize, prioritize, and execute multiple tasks">
  • Ability to work effectively cross-culturally and cross-functionally">
  • Advanced literacy in MS Office">
  • Proficiency in English, both spoken and written">

What We Offer

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We offer a competitive salary of $80,000 - $110,000 per year, depending on experience. Additionally, we provide:

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  • ">
  • A friendly and supportive working environment">
  • Opportunities for career growth and professional development">
  • A global network of colleagues">
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off">

About the Salary

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The estimated salary range for this role is based on industry standards and takes into account the level of experience required for the position. The actual salary offered may vary based on individual qualifications and performance.

Contact Information

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Please note that this job description does not include contact information, such as email addresses or phone numbers. If you are interested in applying for this role, please submit your application through our website or other approved channels.


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