Kavitha Srinivasan
Chennai
Summary
Dynamic Pharmacovigilance Manager with over 9 years of extensive experience in safety review and adverse event management. Proficient in Argus core, with a strong background in overseeing team operations, ensuring compliance with client procedures, and driving continuous improvement initiatives. Expertise in evaluating case reports and providing strategic medical input during critical assessments. Committed to maintaining high-quality standards and optimizing resource utilization for enhanced operational efficiency. Ready to leverage comprehensive knowledge in pharmacovigilance to contribute to organizational success and patient safety. Seasoned Senior Pharmacovigilance Specialist boasting experience in monitoring, identifying, and evaluating adverse drug reactions. Strengths lie in clinical data analysis, global regulatory compliance, and risk management strategies. Known for fostering cross-functional collaborations to mitigate safety risks while ensuring optimal patient care. Previous role impact includes streamlined reporting processes leading to improved efficiency in safety signal detection.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Life Insurance Advisor
Axis Max Life Insurance
Chennai
02.2025 - Current
- Advised a diverse portfolio of clients on term life, whole life, and ULIP insurance plans.
- Conducted detailed financial needs assessments to offer tailored solutions.
- Educated clients on product options, benefits, and coverage suitability.
- Offers periodic reviews and builds a lasting relationship.
Deputy General Manager
Accenture Solutions Pvt Ltd.
Chennai
05.2023 - 12.2024
- Coordinated with clients and teams to ensure timely delivery of all project outputs.
- Motivated team members by articulating clear project objectives and fostering collaboration.
- Allocated Safety Review cases effectively among team members to optimize performance.
- Engaged clients in discussions to build trust and identify requirements, addressing process gaps.
- Served as primary contact for client escalations, responding to queries and resolving issues proactively.
- Developed comprehensive process overviews to enhance understanding of competitive landscape and client expectations.
- Informed project manager and delivery lead of task progress, issues, and overall status.
- Facilitated communication to resolve integration challenges with cross-functional teams.
Safety Review (Full Data Entry) Non-Serious Team Lead
Accenture Solutions Pvt. Ltd.
Chennai
02.2020 - 05.2023
- Responsible for allocating Safety Review cases to the team members.
- Plan, organize, and manage daily work to meet service level timelines and deliverables.
- Responsible for escalating the issues or tasks outside the normal scope of work.
- Ensure client SOPs are applied by the team members.
- Perform daily responsibilities in accordance with all applicable Standard Operating Procedures (SOPs), conventions and client policies.
- Evaluate team member's adverse event case reports for performance achievement.
- Plan and ensure effective and efficient resource utilization, together with the Safety Review manager.
- Define or interpret day-to-day business objectives.
- Provide medical input on difficult adverse event cases.
- Serve as a point of contact between the Accenture and the client team.
- Identify, support and implement continuous improvement activities.
- Facilitate therapeutic area group meetings together with medical reviewers.
- Participate and anchor weekly training, management calls.
- To assist the team in production during spikes in volume and whenever required.
- Responsible for quality of the work delivered and manage incidents with Corrective and Preventive Actions.
Medical Services Senior Analyst
Accenture Solutions Pvt. Ltd.
Chennai
09.2018 - 02.2020
- Coordinate, manage and monitor workings of various processes in the organization.
- Improve processes and policies in support of organizational goals.
- Monitor adherence to rules, regulations and procedures.
- Coordinate and monitor the work of various sections involved in production, monitor performance and implement improvements.
- Provide technical support where necessary.
- Facilitate coordination and communication between support functions.
- Liaison with senior management.
- Assist in the development of strategic plans for operational activity.
- Implement and manage operational plans.
- Work with HR and recruitment to ensure timely mobilization of manpower (including definition of JDS and selection of candidates).
- Ensure adherence to output targets at desired quality levels.
- Analyze MIS and take corrective action where required.
- Recruit and reward high performing individuals to meet goals.
- Facilitate resource evaluation needs across sites.
- Ensure team members receive the necessary training to perform their job functions effectively and consistently within regulations.
- Understand and work to the current divisional/departmental SOPs and SPIs, ensuring deviations are documented appropriately.
- Propose new and revise current procedures as appropriate.
- Lead and work with the teams to optimize processes and use of pharmacovigilance-related technology to build a more efficient organization.
- Encourage practical applications of new ideas.
- Formulate decisions and prioritize implementation of enhancements.
- Ensure adherence to client's policies and procedures.
- Maintain procedures in adherence to the client's policies.
Medical Services Analyst
Accenture Solutions Pvt. Ltd.
Chennai
11.2015 - 09.2018
- Processing and evaluation of Serious Adverse Events/Post Marketing Adverse Events to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality.
- Ensure accurate and consistent coding of medical history, drugs and adverse event terms.
- Assess adverse event reports for seriousness, causality and expectedness as per applicable labeling, consulting the Medical Safety Expert whenever needed.
- Alert the Medical Safety Physicians to potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of product as appropriate.
- Participate in cross-functional teams on safety matters/DS&E special projects relating to investigational and marketed drugs.
- To participate in audits or inspections.
- Ensure that Post Marketing Adverse Events are evaluated accurately and within the required timeframes to meet regulatory requirements.
- Trained by different country organizations for follow-up activities.
Research Associate
PAR Biosciences Pvt. Ltd.
08.2014 - 10.2015
- Sample Preparation Chemist - Involved in sample preparation (Plasma, Serum and Blood samples) to estimate the bio availability and bio equivalence of the active pharmaceutical ingredient.
Education
M.Pharmacy - Pharmaceutical Chemistry
College of Pharmacy, Madras Medical College
Chennai01.2012
B.Pharmacy -
Sankaralingam Bhuvaneswari College of Pharmacy
Sivakasi01.2008
Skills
- Leadership and teamwork
- Self-motivation
- Critical thinking and problem-solving
- Conflict resolution
- Quick learner
- Decision-making
- Effective time management
- Multitasking ability
- Microsoft Office proficiency
- Customer service excellence
- Team collaboration
- Ability to work under pressure
- Adaptability skills
- Communication proficiency
- Time management expertise
- Argus Core proficiency
- Drug discovery software knowledge
- GLIDE expertise
- Client relationship management
- Risk assessment skills
- Team coordination abilities
- Project management expertise
- Data entry accuracy
- Insurance product knowledge proficiency
- Sales strategy development
- Policy review skills
Certification
- Lean Six Sigma Green Belt Certificate, Chennai, Tamilnadu, 06/01/18, Present, Lean Six Sigma Green Belt certification is a highly valued credential that signifies a professional's expertise in improving business processes, reducing waste and enhancing quality.
- IRDAI license, Chennai, Tamilnadu, 02/01/25, Present, IRDAI License is required to sell life insurance in India.
Timeline
Life Insurance Advisor
Axis Max Life Insurance
02.2025 - Current
Deputy General Manager
Accenture Solutions Pvt Ltd.
05.2023 - 12.2024
Safety Review (Full Data Entry) Non-Serious Team Lead
Accenture Solutions Pvt. Ltd.
02.2020 - 05.2023
Medical Services Senior Analyst
Accenture Solutions Pvt. Ltd.
09.2018 - 02.2020
Medical Services Analyst
Accenture Solutions Pvt. Ltd.
11.2015 - 09.2018
Research Associate
PAR Biosciences Pvt. Ltd.
08.2014 - 10.2015
M.Pharmacy - Pharmaceutical Chemistry
College of Pharmacy, Madras Medical College
B.Pharmacy -
Sankaralingam Bhuvaneswari College of Pharmacy
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