Senior Specialist- Pharmacovigilance
Senior Specialist- Pharmacovigilance
Cencora
Job description
Want to take your career in pharmacovigilance and medication safety systems to the next level? Explore the Senior Specialist, Pharmacovigilance System role at Cencora in Noida.
Company Description
Cencora is a global pharmaceutical solutions organization linking pharmaceutical makers, healthcare professionals and patients. It provides access to medications and healthcare services through its international network, technology and industry knowledge. The company is committed to improving health outcomes and helping to offer critical treatments around the world.
Job Summary
The role of Senior Specialist, Pharmacovigilance System is based in Noida. The candidate will be responsible for the management of pharmacovigilance technology platforms; from gathering business requirements and testing system changes to installation and ongoing maintenance. The expert will cooperate with pharmacovigilance operations, regulatory affairs, quality assurance and IT teams to ensure compliance systems, improve workflows and support reliable drug safety processes.
Key Responsibilities
Manage pharmacovigilance platforms comprising drug safety databases, signal detection, medical information tools, literature monitoring solutions and regulatory reporting apps.
Maintain system development plans and prioritize upgrades, enhancements and new features based on business needs.
Manage system activities throughout the life cycle including requirements gathering, user acceptance testing (UAT), deployment, and retirement.
Develop and maintain system documentation such as business requirements documents, functional specifications, standard operating procedures, user guides and validation plans.
Work with pharmacovigilance operations, medical affairs, regulatory affairs, quality assurance and IT to ensure business and technical requirements are aligned.
Translate regulatory and operational needs into explicit technological requirements for system development and enhancement.
Establish partnerships with outside technology vendors and platform providers, addressing concerns and organizing required upgrades.
Coordinate stakeholder communication, user training and change management operations to launch and upgrade support systems.
Evaluate the potential application of new technologies, particularly artificial intelligence and machine learning applications, to pharmacovigilance workflows.
Ensure pharmacovigilance systems comply with applicable regulatory requirements, including ICH E2B(R3), FDA requirements, EMA advice and Good Pharmacovigilance Practices.
Contribute to making strategic choices regarding pharmacovigilance technology investments, platform selection and system portfolio development.
Educational Qualification
A bachelor’s degree in Life Sciences, Pharmacy, Nursing, Health Informatics or a similar field.
3 years of experience in pharmacovigilance, medication safety or similar domain.
Skills Required
Knowledge of the medication safety lifecycle including individual case safety reports, aggregate reporting and signal management.
Experience in a regulated GxP environment and with verified systems.
Exposure to safety databases, case management processes and the maintenance of Individual Case Safety Reports (ICSRs).
Knowledge of E2B(R3), MedDRA coding, CIOMS reports, PSUR/PBRER reporting flows.
Knowledge of signal management tools, adverse event reporting systems and timescales for regulatory submissions .
EudraVigilance and the FDA Adverse Event Reporting System (FAERS) knowledge
Understanding of regulatory structures such as ICH recommendations, GVP modules, GAMP 5 and 21 CFR Part 11.
Understanding of system validation, computerized system assurance, data integrity and audit trail requirements.
Knowledge of uses of machine learning and artificial intelligence in drug safety, e.g. automated coding, literature surveillance and signal identification.
Strong communication and stakeholder management with business and technical teams.
Analytical thinking, problem solving and decision making ability.
Experience in coordinating, negotiating and managing vendor relationships.
Ability to explain system risks, operational difficulties and recommendations to senior stakeholders.
Salary Structure
The average salary of a Senior Specialist- Pharmacovigilance, ranges between ₹6 Lakhs to ₹7 Lakhs per year.
Career Development
This position might be a stepping stone to pharmacovigilance systems management, drug safety technology leadership, regulatory compliance or pharmacovigilance program management. System governance, regulatory requirements, verified platforms, and new artificial intelligence (AI) technologies provide opportunities to gain experience to assist career growth.
How to Apply
Visit our job portal and search for Senior Specialist- Pharmacovigilance.
Click the listing to discover full details, eligibility criteria and experience requirements.
Fill in the application form with your details and attach your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
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