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General Manager (And Above)

12+ years
Not Disclosed
10 Nov. 6, 2025
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

Role: General Manager (and Above)

Qualification: MBBS/MD with a minimum of 12 years of experience

Mandatory Expertise: Medical Writing and Signal Management


Key Responsibilities

Client Relationship Management

  • Serve as the primary point of contact for assigned clients, fostering long-term partnerships built on trust and excellence.

  • Develop a deep understanding of client objectives, therapeutic areas, and business priorities within pharmacovigilance and clinical research.

  • Lead cross-functional collaboration across pharmacovigilance, medical writing, clinical operations, and data management teams to ensure cohesive service delivery.

  • Conduct regular client meetings, presentations, and performance reviews to monitor progress, discuss deliverables, and identify opportunities for improvement.

  • Proactively manage and resolve client issues, ensuring timely escalation and effective resolution.

Pharmacovigilance Expertise

  • Provide strategic oversight and subject matter expertise in the preparation and review of aggregate safety reports (PBRERs, DSURs, PSURs).

  • Lead and ensure compliance in the development, maintenance, and submission of Risk Management Plans (RMPs) in accordance with global regulatory requirements.

  • Oversee and participate in signal detection and evaluation activities, including data analysis, risk assessment, and documentation.

  • Deliver high-quality safety writing, including regulatory responses, benefit–risk evaluations, and ad hoc safety reports.

  • Uphold the highest standards of quality, compliance, and timeliness across all deliverables.

  • Demonstrate hands-on experience in ICSR case processing, coupled with strong leadership and mentoring capabilities.

Clinical Research Support

  • Partner with clinical research teams to integrate pharmacovigilance considerations into study protocols, safety monitoring plans, and clinical documentation.

  • Align pharmacovigilance deliverables with clinical trial timelines and regulatory milestones to ensure end-to-end compliance and efficiency.