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Pharmacovigilance Executive

1-8 years
Not Disclosed
10 June 27, 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, 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 Description


Location: Mumbai
 

The jobholder is responsible for independently drafting, negotiating, and finalizing new agreements, and amendments to existing agreements, in accordance with Pharmacovigilance Agreement (PVA) standard operating procedures. This will include the following activities:

Key Responsibilities:

  • Drafting Agreements: Prepare agreements based on approved PVA templates.
  • Coordination: Gather input from relevant parties for inclusion in agreements.
  • Compiling Agreements: Assemble and finalize agreements.
  • Negotiation: Determine the company’s position and negotiate terms of the agreement with third parties.
  • Review and Sign-off: Coordinate review cycles and obtain necessary sign-offs.
  • Implementation: Implement agreements and ensure they are executed correctly.
  • Maintenance: Maintain and update existing agreements as necessary.
  • Database Management: Ensure accuracy and currency of agreements in the Pharmacovigilance Tracking Database and maintain status updates of all agreements and ongoing work.
  • Query Management: Handle Safety Data Exchange Agreement (SDEA) queries.

Desired Skills:

  • Experience in Pharmacovigilance
  • Strong drafting and negotiation skills
  • Ability to coordinate and manage multiple tasks effectively
  • Attention to detail and strong organizational skills
  • Proficiency in database management

Job Function: Business Process Services
Role: Executive