Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Case Specialist

Product Life Group
Product Life Group
3+ years
Not Disclosed
10 March 26, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Case Specialist (ProductLife Group - Philippines, Remote Possible)
Location: Philippines
Category: Safety and Vigilance
Contract Type: Permanent

About ProductLife Group:
ProductLife Group is seeking a dedicated Case Specialist to join our dynamic team and contribute to the ongoing activities performed within the Hub.

Key Responsibilities:

  • Vigilance Case Management:

    • Data entry of vigilance cases into relevant databases following applicable conventions.

    • Quality control (QC) of vigilance cases and safety-related documents.

    • Medical review of vigilance cases according to conventions and regulatory requirements.

    • Follow-up on vigilance cases through phone or email.

    • Pre-analysis of complex cases before data entry.

    • Identification of submission requirements for safety cases.

  • Analysis and Review:

    • Identify requirements for ICSR/MLM filter preparation.

    • Review and analyze ICSRs downloaded from competent authority databases.

    • Perform reconciliations (partners, medical information, quality complaints).

    • Participate in the operational implementation of new projects.

    • Act as key contact for projects with the support of the team leader, activity manager, or project manager.

  • Medical Review and Operations Lead:

    • Perform medical review of post-marketing cases as assigned.

    • Serve as the Operations Lead for assigned post-marketing clients.

  • Documentation and Compliance:

    • Draft and update technical agreements, safety management plans, and client templates.

    • Draft and update SOPs, WPDs, training materials, and other related documents.

    • Participate in process implementation, maintenance, and continuous improvement.

Education and Experience:

  • Pharmacist or Life Sciences degree with over 3 years of experience in pharmacovigilance.

  • Strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.

  • Minimum 3 years of experience working for service providers performing QC of cases.

  • Experience using SafetyEasy database.

Required Skills/Competencies:

  • Proven ability to meet deadlines and manage multiple projects.

  • Strong communication skills with clients.

  • Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.

  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).