Pharmacovigilance Services Specialist
Company: Accenture
Location: Chennai, India
Job No.: AIOC-S01663790
Employment Type: Full-Time
Experience: 2–5 Years
Qualification: MBBS
Function: Pharmacovigilance Services / Medical Affairs
Position Overview
Accenture is seeking a Pharmacovigilance Services Specialist with an MBBS qualification and relevant pharmacovigilance experience to support medical review and safety activities for pharmaceutical clients.
The role focuses on medical review of Individual Case Safety Reports (ICSRs), assessment of adverse events, medical coding, seriousness and causality evaluation, safety reporting, and compliance with global pharmacovigilance requirements.
The position may also involve supporting Medical Affairs-related business solutions and working with pharmaceutical clients on various medical and scientific initiatives.
Key Responsibilities
Medical Review and Pharmacovigilance
Perform medical review of Individual Case Safety Reports (ICSRs).
Assess adverse events for medical accuracy and clinical relevance.
Review MedDRA coding for appropriateness and consistency.
Evaluate case seriousness and causality.
Assess cases against applicable product labeling requirements.
Review source documentation to verify medical accuracy and completeness.
Identify missing or clinically relevant information.
Provide medical expertise and guidance to case processing teams.
Ensure compliance with global pharmacovigilance regulations, SOPs, quality standards, and audit requirements.
Apply knowledge of global safety reporting requirements to assigned activities.
Affiliate Mailbox and Follow-Up Management
Manage the affiliate mailbox in accordance with established processes.
Reconcile incoming safety reports and ensure appropriate processing.
Perform written follow-up activities for both serious and non-serious cases.
Track follow-up activities and ensure required information is obtained and documented appropriately.
Maintain accurate records throughout the case lifecycle.
Medical Affairs Support
Support the development and delivery of business solutions for pharmaceutical Medical Affairs organizations.
Contribute to medical publications and scientific communication initiatives.
Support medical education and information activities.
Assist with medical grant-related activities.
Support advisory board activities.
Contribute to advocacy-related initiatives where required.
Apply medical and scientific knowledge to support client-specific solutions.
Quality and Compliance
Ensure assigned pharmacovigilance activities comply with applicable regulations and internal SOPs.
Maintain high standards of quality and accuracy in medical review activities.
Support audit readiness and address quality-related requirements.
Identify potential compliance issues and escalate them appropriately.
Ensure safety information is assessed and documented accurately.
Problem Solving and Process Improvement
Analyze and resolve moderately complex pharmacovigilance problems.
Apply existing procedures and methodologies while adapting them when appropriate.
Develop solutions for new or challenging assignments under appropriate guidance.
Understand team objectives and align activities with the strategic direction established by senior management.
Contribute to continuous improvement of pharmacovigilance processes and service delivery.
Team and Stakeholder Management
Work closely with supervisors, peers, management, and client stakeholders.
Provide medical and pharmacovigilance expertise to case processing teams.
Support small teams or work efforts where required.
Communicate effectively with internal and external stakeholders.
Make decisions that positively impact assigned teams and project deliverables.
Seek guidance from senior team members when handling new or complex assignments.
Required Qualifications
MBBS degree is required.
2–5 years of relevant pharmacovigilance experience.
Experience in medical review of ICSRs.
Experience with adverse event assessment.
Knowledge of MedDRA coding.
Understanding of seriousness and causality assessment.
Knowledge of global safety reporting requirements.
Understanding of pharmacovigilance regulations and SOPs.
Experience with ICSR review and case processing.
Knowledge of WHO Drug and relevant safety databases is preferred.
Key Skills
Medical review of ICSRs.
Pharmacovigilance and drug safety.
Adverse event assessment.
MedDRA coding.
WHO Drug.
Seriousness and causality assessment.
Global safety reporting.
Affiliate mailbox management.
Follow-up case management.
Medical terminology.
Strong analytical and problem-solving skills.
Good written and verbal communication.
Attention to detail.
Ability to work effectively in a team environment.
Additional Requirements
The role may require working in rotational shifts.
Ability to work in a client-facing and service-oriented environment.
Ability to understand and follow strategic direction provided by senior management.
Ability to manage assigned work independently while seeking guidance when required.
About Accenture
Accenture is a global professional services organization providing services across Strategy and Consulting, Technology, Operations, and digital capabilities.
The company combines technology and human ingenuity to help organizations transform their businesses and create value. Accenture operates across numerous industries and serves clients globally.
Work Culture and Development
Accenture promotes an inclusive and collaborative work environment that encourages innovation, continuous learning, and professional development.
Employees have opportunities to develop their skills through certifications, training programs, diverse work experiences, and career development initiatives.
Equal Employment Opportunity
Accenture is committed to equal employment opportunity and an inclusive workplace. Employment decisions are made without discrimination based on legally protected characteristics in accordance with applicable laws and regulations.
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