Senior Pharmacovigilance Specialist

hace 6 días


Barcelona, Barcelona, España Tfs Healthscience A tiempo completo

**About Tfs Healthscience**: We are a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.

**Job Description:**

We are seeking a highly motivated Senior Pharmacovigilance Specialist to join our SRS/FSP team. As a key member of the team, you will be dedicated to one sponsor, an international pharmaceutical company that is an industry leader.

**Key Responsibilities:**
  • Handling of Serious Adverse Events (SAEs) in clinical trials and spontaneous reports from the market, ensuring collection, assessment, and entry into the safety database in accordance with the TFS/client SOPs and existing demands of authorities.
  • Review and approval of processed cases and AE/SAE reconciliation.
  • Coding of adverse events, medical history, and concomitant medication according to MedDRA and WHO-Drug Dictionary.
  • Quality control and approval of coding of adverse events, medical history, and concomitant medication.
  • Review and writing of the safety section in clinical study protocols.
  • Review of clinical trial reports/IBs from a safety perspective.
  • Writing the safety parts in PSUR/PBRER, DSURs, IND, NDA, and other safety documents.
  • Literature search.
  • Electronic reporting to EudraVigilance.
  • Contribution to plans/instructions and SOPs for post-approval surveillance.
  • Updating of templates for safety handling in specific studies/projects according to relevant SOPs.
**Requirements:**

To be successful in this role, you should have:

  • Bachelor's Degree, preferably in life science or nursing; or equivalent.
  • At least 3 years of experience in the position.
  • Able to work in a fast-paced environment with changing priorities.
  • Understanding of medical terminology and science associated with assigned drugs and therapeutic areas.
**What We Offer:**

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.



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