Vikrant Saini
Mohali
Summary
- Analytical and dedicated professional offering close to twelve years of experience in Pharmacovigilance, case processing, individual case safety reports (Pre and Post-marketing cases), query management, compliance investigations, MedDRA coding, and data validation. Proven accomplishments in building and mentoring a team to achieve the company's and personal goals. Possess in-depth understanding of drug safety reporting (European and US region) and proven skills in coordinating and leading variety of people and projects with an ability to develop strategic plans. Five years of experience in project management with specialization in set up and automation of book-in process along with global and local literature process.
Overview
9
9
years of professional experience
Work History
SENIOR MANAGER, PV OPERATIONS
Parexel International
Mohali
04.2023 - Current
- Managed the daily operations of multiple departments to maximize efficiency
- Consistently met and exceeded company goals
- Implemented cost-saving initiatives to reduce overhead costs
- Analyzed data from various sources to identify trends and make actionable recommendations for improvement
- Managed multiple projects and priorities in a fast-paced environment
- Managed multiple high-priority projects simultaneously while meeting tight deadlines
- Built strong relationships with sponsors
- Measured staff and process productivity and utilized results to make helpful equipment and staffing adjustments
- Evaluated operational costs and identified areas of improvement
- Successfully managed and developed a team of 35+ employees, demonstrating strong leadership skills
MANAGER
Parexel International
Mohali
03.2019 - 03.2023
- Led team to process daily case procedures, identify areas of improvements, develop, and implement plans to steer
- Business process
- Improve performance delivery by allocating resources in line with budget and set schedule
- Support
- Senior management with innovative ideas and impeccable strategies leading to business and revenue growth
- Suggestion
- To clients to improve efficiencies of the processes and coming with innovative ideas
- Training team members to improve
- Key Contributions:
- Increased revenue for the projects exponentially by winning more business activities
- Involved in supporting ad-hoc requests from clients
- Part of initiatives apart from daily routine activities
- Best feedback from the clients
ASSOCIATE TEAM MANAGER
Parexel International
Mohali
11.2018 - 02.2019
- Responsible for providing guidance and direction to a team of drug safety associates
- Setting goals for staff and assessing individual performance and achievements according to company HR processes
- Managing people development and talent management
- Performing regular reviews for team members and providing appropriate feedback
- Ensuring data collection and preparation of metrics is provided to senior management on a regular basis
- Plan and schedule activities and deliverables
- Plan and manage resources
- Monitor progress according to the client's requirements
- Primary contact for client communication
- Planned daily, monthly, and annual work capacities for the team
- Established capacities and distributing work as per incoming workflow
- Conducted refreshers and trainings for the case processing team
- Interaction with internal or external contacts to resolve issues related to the processing of ICSRs
- Liaison with Project Manager/Team Leads to understand the training needs of team members, as required
- Involved in Business Contingency Planning, Pandemic Planning, and Inspection Readiness
PHARMACOVIGILANCE SPECIALIST
Parexel International
Mohali
04.2015 - 10.2018
- PHARMACOVIGILANCE ANALYST - Quantum Solutions India, Chandigarh, April 2014 - March 2015
- PHARMACOVIGILANCE SCIENTIST - Quantum Solutions India, Chandigarh, December 2012 - March 2014
- Drug Safety Experience:
- Expertise in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous
- Clinical studies and solicited programs) which includes:
- Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines
- Within which they need to be submitted to the regulatory authorities
- Initiation/registration of ICSRs into the safety database
- Conducting duplicate searches prior to initiation and identifying potential duplicates
- Managing duplicate couples/cases appropriately
- Data entry of ICSRs in the safety database, including determining the expectedness of adverse
- Events against various labeling documents (such as SPC, CDS, IB etc.), writing case summaries, assessing
- Causalities if required and writing CIOMS comments if required
- Data validation i.e
- Cross checking against source documentation
- Expertise in MedDRA coding in accordance with "MedDRA Term Selection: Points to Consider"
- Expertise in managing safety data on various safety databases
- Maintaining a good working knowledge of the AE safety profile of assigned drugs/class of drugs, Reference Safety
- Information documents, data entry conventions and guidelines, aggregate reporting conventions and guidelines, client's
- Procedures and international drug safety regulations including:
- Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with
- Internal and regulatory timelines for adverse event reporting
- Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in accordance with
- Client's policies
- Responding to clients/customers in a timely manner
- Expertise in handling the Enterprise Resource Planning (ERP) system
Literature Experience
Parexel International
Mohali
- Expertise in processing literature cases which include cases from medical journals abstracts, poster presentation
- Literature summary cases and full literature articles including clinical cases (including interventional and noninterventional
- Case studies) and spontaneous reports
- Have been communicating with the authors for the required
- Information on articles
- Have experience in review and validity assessment of articles, triage, duplicate searches
- Registration, MedDRA coding, AE text writing, QC of literature (both clinical and spontaneous) reports, query
- Identification and tracking
- Local Literature Screening Experience
- Handling local literature screening for non-indexed journals of various countries
- Conducting weekly screening of non-indexed journals for list of products provided by country specific
- Affiliates
- Sending weekly notifications to affiliates stating incoming for the week, number of valid citations for
- ICSRs and PSUR's
Training & Mentoring Experience
- Received training as a trainer ("Train the Trainer") and mentor
- Provided training to Drug Safety Associates on case coding and good pharmacovigilance practices
- Mentored Drug Safety Associates to ensure confident coding of ICSRs
- Providing training to affiliates located at different sites via live meetings
Education
MASTER OF PHARMACY - PHARMACEUTICS
Chitkara College of Pharmacy, Chitkara University
Rajpura, Punjab01-2012
BACHELOR OF PHARMACY -
Swami Devi Dyal Institute of Pharmacy
Barwala, Haryana01-2010
Skills
- Strategic Planning and Development
- Attention to Detail and Accuracy
- Regulatory Compliance and Protocols
- Compliance Investigations
- Case Management
- Project Management
- Team Leadership and Mentoring
- CAPA writing
- Process Optimization
- Proven skills in people management
- Employee Coaching and Motivation
- Managing Operations and Efficiency
- Safety Regulations
- Quality Standards
Personal Information
Title: Senior Manager, PV Operations
References
- Neha Thakur, Parexel International PVT LTD, Director, neha.thakur2@parexel.com
- Rahul Arora, Deputy Director and Head Pharmacovigilance and Safety, (981) 502-8600, drarorarahul@gmail.com
Languages
English
First Language
Hindi
Proficient (C2)
C2
Punjabi
Proficient (C2)
C2
Timeline
SENIOR MANAGER, PV OPERATIONS
Parexel International
04.2023 - Current
MANAGER
Parexel International
03.2019 - 03.2023
ASSOCIATE TEAM MANAGER
Parexel International
11.2018 - 02.2019
PHARMACOVIGILANCE SPECIALIST
Parexel International
04.2015 - 10.2018
Literature Experience
Parexel International
Training & Mentoring Experience
MASTER OF PHARMACY - PHARMACEUTICS
Chitkara College of Pharmacy, Chitkara University
BACHELOR OF PHARMACY -
Swami Devi Dyal Institute of Pharmacy
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