Manager (Medical Doctor), Global Market Vigilance (GMV)

2 days ago

Anekal, Karnataka, India Unilever Full time

Job Title:
Manager (Medical Doctor), Global Market Vigilance (GMV)

Location:
Unilever Bangalore R&D

Function:
Global Regulatory Affairs (GRA), Wellbeing Collective (WBC)

Job Summary
The ideal candidate is a medical doctor who can leverage their healthcare professional background and hands-on experience in Pharmacovigilance to ensure the highest standards of safety assessment and regulatory compliance. The role applying clinical judgment, conducting in depth adverse event reviews, and contributing proactively to ensure the safety of our products and consumers.

Key Responsibilities

  • Case Assessment and Medical/ Clinical Review:

  • Conduct comprehensive and in-depth review of health-related complaints (i.e. adverse events or AEs) regarding our products received from various sources (consumers, healthcare professionals, clinical studies, etc.)

  • Evaluate case seriousness, expectedness, and identify any missing or incomplete information while ensuring data integrity and accuracy.
  • Ensure all AEs are documented and coded accurately using industry-standard medical terminologies like MedDRA (Medical Dictionary for Regulatory Activities).

  • Actively participate in the analysis of aggregate safety data to identify potential safety signals or trends.

  • Global Regulatory Compliance and Quality Assurance:

  • Ensure all medical review and case processing activities are executed in strict adherence to a complex web of global and local regulatory requirements (e.g., FDA 21 CFR 312, EMA Good Pharmacovigilance Practices (GVP), etc.) and internal Standard Operating Procedures (SOPs).

  • Contribute to internal and external audits and inspections, acting as a subject matter expert on adverse event case management.

  • Strategic Cross-Functional Collaboration:

  • Serve as a key liaison for safety-related inquiries from internal partners, including Legal, Marketing, R&D, and Quality Assurance.

  • Mentorship and Continuous Improvement:

  • Serve as a mentor to team members working in AE management process and provide training as well as guidance on case assessment approaches.

  • Identify and propose improvements to existing workflows and tools to enhance efficiency, accuracy, and compliance within the GMV team.

Required Skills, Qualifications, And Experience

  • Education: Medical degree (MBBS or MD) from an accredited institution is required.

  • Experience:

  • Minimum of 3+ years of strong expertise in pharmacovigilance and patient/ consumer safety working in the Pharmaceutical, Medical Device or Consumer Healthcare industries.

  • Extensive firsthand experience using global pharmacovigilance databases. Experience with Veeva Vault Safety is highly desired.
  • Ability to perform robust medical reviews and assessments of adverse event and serious adverse cases.

  • Well versed in safety & causality assessments, medical narrative writing, using MedDRA coding and reviewing MedWatch and CIOMS reports.

  • Technical and Professional Skills:

  • Medical and Scientific Knowledge: Strong foundational understanding of human physiology, clinical pharmacology as well as side effects associated with use of pharmaceuticals, medical devices, consumer products etc. Ability to apply this knowledge to interpret consumer complaint information, clinical data, lab results, and medical reports.

  • Regulatory Acumen: In-depth knowledge of global pharmacovigilance regulations, guidelines, and industry best practices (especially US FDA, Health Canada).
  • Communication & Collaboration: Exceptional ability to communicate complex medical concepts clearly and concisely, both verbally and in writing, to both scientific and non-scientific audiences.
  • Analytical Rigor: Excellent critical thinking and critical thinking skills with a meticulous diligence and a high degree of accuracy.

Our commitment to Equality, Diversity & Inclusion
Unilever embraces diversity and encourages applicants from all walks of life This means giving full and fair consideration to all applicants and continuing development of all employees regardless of age, disability, gender reassignment, race, religion or belief, sex, sexual orientation, marriage and civil partnership, and pregnancy and maternity.

"All official offers from Unilever are issued only via our Applicant Tracking System (ATS). Offers from individuals or unofficial sources may be fraudulent—please verify before proceeding."

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