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Drug Safety Officer

2+ years
Not Disclosed
10 Dec. 12, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Responsibilities:

  • Act as the Local Contact Person for Pharmacovigilance (PV), overseeing all PV-related activities.
  • Conduct local literature searches and reviews, ensuring the quality and accuracy of results; maintain updated lists of journals and conferences.
  • Manage case reports, complaints, and queries, ensuring proper handling from collection through to reporting to clients and regulatory authorities.
  • Prepare and review aggregate safety reports, such as PSURs/PBRERs, ensuring compliance with regulatory requirements.
  • Assist in the creation and implementation of Risk Management Plans (RMPs) and other safety-related documents.
  • Support additional risk minimization activities as required by the organization or regulatory bodies.
  • Facilitate communication with external stakeholders, including clients, regulatory authorities, and local collaborators, ensuring smooth and effective collaboration.
  • Submit or assist in the submission of vigilance-related documents and reports to regulatory authorities.
  • Contribute to the maintenance and updating of the Pharmacovigilance system and processes.

Minimum Requirements:

  • A Medical Doctor, Licensed Healthcare Professional, Pharmacist, or graduate in Health or Life Sciences, or a relevant degree.
  • A minimum of 2 years of experience in a Safety Officer role, or equivalent experience related to the responsibilities of a Safety Officer.
  • Fluency in English, with strong communication and organizational skills.
  • Proficient in Microsoft Outlook, Word, Excel, and PowerPoint.
  • Demonstrated sense of responsibility, confidentiality, and attention to detail in managing documents and trackers.
  • Strong multitasking abilities, with a proactive and self-motivated approach.
  • Excellent time management skills, the ability to work independently and within teams, and adaptability to changing priorities.
  • Ability to perform training, present information clearly, and focus on achieving goals and results.
  • Client-focused and problem-solving mindset, able to prioritize effectively and work with minimal supervision.