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Pharmacovigilance Agreements Specialist

Tcs
TCS
3-7 years
preferred by company
Mumbai, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Job Title: Pharmacovigilance Agreements Specialist

Location: Mumbai, Maharashtra, India
Job Type: Full-Time
Experience Required: 3–7 Years (Freshers are not eligible)
Industry: Pharmacovigilance / Drug Safety / Pharmaceuticals / Life Sciences / Healthcare
Department: Business Process Services / Pharmacovigilance Operations

About the Role
We are seeking a highly detail-oriented Pharmacovigilance Agreements Specialist to join a growing pharmacovigilance operations team in Mumbai. This role is ideal for professionals with hands-on expertise in pharmacovigilance agreements, drug safety compliance, global pharmacovigilance regulations, and contractual governance within pharmaceutical or life sciences organizations.

The ideal candidate will be responsible for drafting, reviewing, managing, and maintaining Pharmacovigilance Agreements (PVAs) while ensuring compliance with global regulatory standards, contractual obligations, and internal governance processes. This opportunity is well suited for professionals with strong experience in pharmacovigilance operations, quality oversight, and cross-functional stakeholder coordination.

Key Responsibilities

Pharmacovigilance Agreement Management

  • Draft new Pharmacovigilance Agreements (PVAs) and revise existing agreements in accordance with organizational standards and regulatory requirements.
  • Review PVAs for completeness, quality, contractual accuracy, and alignment with internal company policies.
  • Ensure all new and revised agreements are compliant with global pharmacovigilance obligations and partner responsibilities.
  • Address internal stakeholder feedback and collaborating company comments during agreement negotiation and revision cycles.

Regulatory Compliance & Pharmacovigilance Governance

  • Ensure pharmacovigilance contractual arrangements comply with ICH guidelines, Good Pharmacovigilance Practices (GVP), and global drug safety regulations.
  • Support compliance monitoring for active PVAs and ensure obligations are effectively documented and tracked.
  • Assist in identifying compliance risks, contractual gaps, and process improvement opportunities.
  • Maintain audit readiness for pharmacovigilance agreement documentation and compliance records.

Documentation Control & Repository Management

  • Upload, organize, and maintain PVAs and associated documentation within the designated company repository.
  • Maintain version control, document accuracy, and secure archival practices for agreement records.
  • Ensure all supporting contractual and governance documentation remains current and accessible.

Tracker Management & Reporting

  • Maintain and update the PVA tracker for all active global pharmacovigilance agreements, reconciliations, and status changes.
  • Monitor key milestones, effective dates, revisions, compliance checkpoints, and outstanding actions.
  • Prepare dashboards, status reports, and compliance metrics for internal stakeholders and management review.

Stakeholder Communication & Operational Coordination

  • Manage the dedicated pharmacovigilance agreement mailbox and coordinate timely responses to stakeholder queries.
  • Communicate new or revised PVAs to relevant internal teams, project stakeholders, and operational functions.
  • Attend team meetings to provide status updates, highlight operational issues, and support resolution planning.
  • Collaborate with project managers, drug safety teams, legal stakeholders, compliance teams, and partner organizations.

Process Improvement & Quality Support

  • Support process optimization initiatives related to agreement lifecycle management and pharmacovigilance governance.
  • Assist in maintaining project documentation, trackers, SOP updates, and operational workflow improvements.
  • Contribute to quality enhancement initiatives within pharmacovigilance contractual operations.

Required Qualifications

  • Bachelor’s degree in Pharmacy (B.Pharm), Life Sciences, Biomedical Sciences, or Bachelor of Science (B.Sc) or a related healthcare discipline.
  • 3–7 years of relevant experience in pharmacovigilance, drug safety operations, pharmacovigilance compliance, or agreement management.
  • Strong working knowledge of global pharmacovigilance regulations, ICH guidelines, Good Pharmacovigilance Practices (GVP), and contractual drug safety obligations.
  • Experience drafting, reviewing, or managing Global and Local Pharmacovigilance Agreements (PVAs) is highly preferred.
  • Strong documentation, contract review, quality assurance, and compliance monitoring skills.
  • Excellent organizational, analytical, and stakeholder communication abilities.
  • Proficiency in Microsoft Office tools, trackers, reporting dashboards, and document repositories.