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    Senior Operations Manager-Pharmacovigilance

    Indegene
    4-15 years
    Not Disclosed
    Bengaluru
    15 May 16, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Senior Operations Manager - Pharmacovigilance

    Company Overview: Indegene is a technology-led healthcare solutions provider dedicated to enabling healthcare organizations to be future-ready. With a focus on innovation, collaboration, and empathy, Indegene offers accelerated global growth opportunities for bold, industrious, and nimble talent. Combining healthcare and technology, Indegene provides a unique career experience that celebrates entrepreneurship and fosters passion and innovation.

    Job Summary: As a Senior Operations Manager, you will oversee the delivery and operations of large engagements in the Pharmacovigilance domain. Your role involves providing direction and driving high client satisfaction by ensuring timely and quality deliveries. This position requires collaboration with teams spread across geographies (US, the EU, and India) to meet customer requirements efficiently, cost-effectively, and compliantly.

    Responsibilities:

    Operations Management - Pharmacovigilance:

    • Provide oversight, review, and monitor compliance with client and regulatory requirements through various monitoring reports and oversight activities.
    • Establish oversight procedures and Key Performance Indicators (KPIs).
    • Generate metrics and provide regular feedback.
    • Participate in internal/client audits and global regulatory inspections as a Subject Matter Expert (SME) for specific PV topics and processes.
    • Adhere to company policies and applicable regulations, including reporting adverse events to regulatory agencies.
    • Provide direct technical/data management support to ensure consistency, accuracy, and completeness of information entered and retrieved from the safety database.
    • Manage and assist in implementing and maintaining a comprehensive risk-based GVP/GCP compliant quality program/systems.
    • Provide input to GVP related Corrective and Preventive Action plans.
    • Identify and remediate performance issues to maintain a state of high PV inspection readiness.
    • Escalate critical and major PV gaps to management for appropriate action.
    • Conduct and participate in PV training for employees on safety reporting responsibilities.
    • Demonstrate proficiency in effectively managing day-to-day operations.

    People Management & Team Development:

    • Foster employee growth by providing a supportive learning and development environment.
    • Manage large teams efficiently.
    • Share experiences for constructive outcomes.
    • Enable team members to discuss aspirations, goals, and shortcomings and develop plans to address these.
    • Provide honest, timely, constructive, and specific feedback on performance.

    Problem Solving and Business Acumen:

    • Understand problems from multiple dimensions and solve them timely.
    • Identify and execute financial drivers to enhance profitability, productivity, and market share.
    • Continuously seek information from current clients and prospects to understand emerging needs and make meaningful interpretations.

    Desired Profile:

    • Minimum 14+ years of experience in operations management, with at least 5 years in a client-facing role and direct pharmacovigilance work experience in the pharmaceutical industry.
    • Postgraduate degree from premium B schools will be a plus.
    • Strong managerial experience, including coaching, communicating expectations, and praising accomplishments.
    • Strong knowledge of electronic systems used to manage clinical trial data and safety reporting (e.g., eTMF, EDC, Argus, ArisG, IVRS), and familiarity with MedDRA and WHO DD dictionaries.
    • Solid clinical knowledge and strong analytical ability.
    • Superior communication skills.
    • Proficiency in financial concepts.
    • Previous experience and formal training with safety database programs, including configuration and validation activities, desired.
    • Ability to deal with multiple stakeholders and manage client expectations.
    • Initiative-taking with excellent interpersonal skills.
    • Good negotiation skills.
    • Passion for networking and updating oneself with the latest market trends.
    • Structured thinking and articulation.
    • Ability to manage pressure and work with multiple stakeholders.

    Equal Opportunity: Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. All employment decisions, from hiring to separation, are based on business requirements, candidate’s merit, and qualification. We do not discriminate on the basis of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristic.

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