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Pharmacovigilance I

0-2 years
Not Disclosed
10 Jan. 23, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Pharmacovigilance I

Experience Required: 0 – 2 Years

Location: [Specify Location]

Job Description:

We are seeking a detail-oriented and motivated Pharmacovigilance I professional to join our team. This entry-level position is ideal for candidates with 0 to 2 years of experience in pharmacovigilance or drug safety. As a Pharmacovigilance I, you will play a key role in monitoring and reporting adverse drug reactions (ADRs), ensuring the safety of pharmaceutical products and compliance with regulatory requirements.

Key Responsibilities:

  • Assist in the collection, processing, and reporting of adverse drug reactions (ADRs) from clinical trials and post-marketing surveillance.
  • Review and evaluate safety data from clinical trials, spontaneous reports, literature, and other sources to identify and assess potential safety signals.
  • Ensure that all safety data is accurately documented and reported in compliance with regulatory requirements and internal procedures.
  • Support the preparation and submission of Periodic Safety Update Reports (PSURs), Individual Case Safety Reports (ICSRs), and other safety-related documents.
  • Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and medical affairs, to ensure timely and accurate reporting of safety information.
  • Assist in the development and maintenance of pharmacovigilance systems, databases, and procedures.
  • Monitor and follow up on safety-related queries, ensuring resolution in a timely manner.
  • Stay up to date with regulatory guidelines and industry best practices related to pharmacovigilance.
  • Participate in safety signal detection and risk management activities as required.

Qualifications:

  • Bachelor’s degree in Pharmacy, Life Sciences, Nursing, or a related field.
  • 0-2 years of experience in pharmacovigilance, drug safety, or related areas (internships or academic projects related to pharmacovigilance are a plus).
  • Basic understanding of pharmacovigilance practices, regulatory requirements (e.g., FDA, EMA), and ICH-GCP guidelines.
  • Knowledge of adverse event reporting, safety signal detection, and risk management is desirable.
  • Familiarity with pharmacovigilance databases and safety reporting systems is a plus.
  • Strong attention to detail and ability to handle sensitive information with confidentiality.
  • Excellent communication, organizational, and problem-solving skills.
  • Ability to work effectively both independently and as part of a team.
  • Proficient in Microsoft Office Suite and related software tools.

This is an excellent opportunity for an entry-level professional to develop expertise in pharmacovigilance and contribute to the safety and well-being of patients. If you are passionate about drug safety and eager to make an impact in the pharmaceutical industry, we encourage you to apply.

Rush your CVs to : careers@clinztech.com