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Pv Assistant Manager

5-8 years
Not Disclosed
10 Oct. 24, 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

Grow with Us!
Are you looking for a dynamic company where daily challenges and opportunities await? Then Pharmalex is the perfect career opportunity for you! As one of the leading service providers in the pharmaceutical industry globally, Pharmalex specializes in all aspects of drug and medical device approvals, market development, and effective product maintenance.

Position: PV Assistant Manager

Location: Noida

Your Role

  • Project Management:
    Oversee management and documentation for assigned pharmacovigilance (PV) projects, ensuring smooth coordination and allocation within the team.

  • Training & Mentoring:
    Train and mentor PV department staff as needed to enhance skills and compliance.

  • Invoicing:
    Ensure timely generation and sharing of monthly invoices for all PV clients.

  • Documentation Compliance:
    Maintain and update departmental CVs, job descriptions, and training records in accordance with standard operating procedures (SOPs).

  • Training Compliance:
    Ensure PV staff consistently meet training compliance requirements.

  • Audit Representation:
    Represent the PV department during client audits or regulatory authority inspections.

  • Quality Assurance Documentation:
    Write and review QA documents such as Safety Data Exchange Agreements (SDEAs), SOPs, working instructions, and templates for PharmaLex PV projects.

  • Training Organization:
    Organize and conduct training on the aforementioned documents.

  • Case Processing:
    Manage case processing activities, including data entry, quality checks, and documentation.

  • Follow-up Requests:
    Prepare and send follow-up requests as needed to ensure case completion.

Your Profile

  • Qualifications:
    B.Pharm, BDS, Pharm D, or M.Pharm.

  • Experience:
    Minimum of 5-8 years in pharmacovigilance or related fields.

How to Apply

If you are interested in joining our PharmaLex team for this exciting opportunity in our forward-thinking company, please submit your application online. Include your earliest possible starting date, any visa requirements, and salary expectations. We look forward to receiving your application!