Pharmacovigilance Technician
Direct message the job poster from Galenicum
BELIEVE IN LIFE. Join a company that takes you further!
Galenicum is one of the fastest growing companies in the pharmaceutical sector! We are enthusiastic about life, devoting our talent and effort to providing high-quality affordable pharmaceuticals worldwide.
People are the key to our present and future success, so we carefully select candidates that meet the requirements for each position, however most importantly, who also fit with our cultural DNA and values.
Here’s the lowdown on what your role will actually look like (spoiler alert: it’s awesome!)
We are looking for a Pharmacovigilance Technician to join our team.
What you'll be rocking:
* To perform the routines pharmacovigilance activities: literature searches focus on identifying adverse drug reactions or safety information; management of spontaneous adverse drug reactions, including MedDRA code, causality, expectedness.
* To manage Safety Data Exchange Agreement.
* Processing of Individual Case Safety Reports (ICSRs): Evaluation, entry, and follow-up of adverse events, ensuring compliance with regulatory timelines.
* Support in Audits and Regulatory Inspections: Preparation and response for pharmacovigilance inspections and audits.
* To manage reconciliation with different partners.
* Regulatory Knowledge: Familiarity with international regulations such as GVP (Good Pharmacovigilance Practices), ICH E2E, EMA, FDA, and local pharmacovigilance requirements (RoW).
* Support to the EUQPPV in the activities that he/she performs including the possibility to carry out the 24h phone.
What you bring to the table:
* One year of experience as an intern in pharmacovigilance tasks.
Educational milestone:
* Excellent level of business English, spoken and written.
* Excellent computer skills, specifically Excel and Word.
Your key superpowers:
* Highly responsible, proactive, dynamic, methodical, decisive and organized individual.
* Excellent oral and written communication and interpersonal skills.
* Knowledge in Pubmed will be a plus.
* Strong analytical frame of mind and problem solving.
* Attention to detail (Precision in case processing and documentation)
* Ability to interpret scientific and pharmacological data to assess potential risks.
* Ability to manage multiple projects and meet strict regulatory deadlines.
What makes Galenicum a top-tier workplace?
* A challenging company, and a dynamic team to work with.
* A Workspace to enjoy. Pleasant, sustainable, and architecture-awarded office.
* A flexible schedule to match your preferences and workload.
* A training offer to learn beyond your job with a broad set of topics: Galenicum Laude.
* Health insurance coverage to feel cared.
* Food to keep your energy up. Subsidized meals in our office restaurant Popina.
* Gym to help you maintain a healthy lifestyle.
* Flexible remuneration.
* And, very important! A Buddy to help you land smoothly in our company since day 1.
We’re looking for someone who works hard, plays hard, and laughs harder. Sound like you?
Come aboard. Believe in life
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research and Quality Assurance
Industries
Pharmaceutical Manufacturing
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