Vikram Thakkar Email and Phone Number
✎Highly accomplished and results-driven with over 12 years of experience in end to end activities in pharmacovigilance, Aggregate reports, Signal management and Risk Management plans. Proven expertise in conducting and handling audits and inspections, ensuring compliance with industry regulations and standards. Adept at leading and motivating cross-functional teams to deliver exceptional results. Skilled in vendor management, forging strong partnerships to enhance operational efficiency and product quality. 𝐊𝐞𝐲 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬:✔Seasoned professional with a successful track record in managing Risk Management plans, Aggregate reports and Signal management.✔Extensive experience in risk management, identifying potential pitfalls and implementing proactive measures to mitigate them effectively.✔ Achieved a consistent reduction of 250 hours per month and 5 FTEs through innovative macro development and implemented an efficient roadmap for streamlining literature processes.✔ Delivered remarkable results by streamlining the PADER automation process in Argus, resulting in impressive savings of over 100 man- hours per month✔Proficient in conducting audits and inspections, maintaining adherence to regulatory requirements and achieving excellence in quality control.✔Adept at team management, fostering a collaborative environment and empowering team members to reach their full potential.✔Skilled in vendor management, cultivating strong relationships with suppliers to ensure seamless procurement and maintain high product standards.✔My unwavering commitment to quality and compliance has consistently led to positive outcomes in the pharmaceutical sector. I have been instrumental in streamlining operations and optimizing processes, resulting in increased productivity and reduced risks.✔Earned five esteemed Bravo awards in recognition of exceptional contributions in process improvement, collaboration, and compliance in Risk Management Plans and literature process, underscoring a commitment to excellence and recognition as a valued team member.Seeking career advancement with an esteemed organization in Product Safety and Risk Management (PSRM) domain, leveraging my in-depth expertise in overseeing global Risk Management Plans (RMPs), conducting meticulous evaluations, and ensuring regulatory compliance, while driving proactive risk management strategies to enhance organizational safety and success.
Gsk
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Principal Serm ScientistGsk Dec 2024 - PresentBangalore Urban, Karnataka, India
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Senior Manager - Medical SafetyApcer Life Sciences Jan 2024 - Nov 2024Ahmedabad, Gujarat, India❖ Leading the team of Risk Management Plans for EU and ROW. Authoring and review of risk management plans for EU and ROW.❖ Preparation and review of effectiveness assessment reports of additional risk minimization measures.❖ Active member in the development of REMS portal.❖ Managing the projects for preparation and maintenance of risk management plan. ❖ Authoring and review of aggregate reports.❖ Providing inputs and contribute to the RFPs. ❖ Generation and review of SOPs and WIs. -
Team LeadApotex Research Private Limited Jun 2020 - Jan 2024Mumbai, Maharashtra, India𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 –❖ Preparation and review of RMP and contribution in the evaluation of effectiveness of additional risk minimization measures.❖ Preparation and quality review of drug safety reports (PADER, PSUR, PBRER).❖ Contribution in signal detection activities.❖ Contribute in process improvement by participating in preparation/revision of SOPs as well as guidance documents/templates per latest version /revision of regulatory guidelines.❖ Miscellaneous activities such as monthly product reconciliation activity, vendor work order reconciliation etc.❖ Mentoring of new team members joined in the team. Reviewing of mock reports and providing feedback to team members.❖ Rewarded 5 times with Bravo Award for statutory compliance, quality assurance and process improvement in literature process and risk management plan. -
Assistant Manager - Global PharmacovigilanceGlenmark Pharmaceuticals Ltd. Jan 2017 - Jun 2020Mumbai, Maharashtra, India𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 –❖ Operational and people management within pharmacovigilance department.❖ Authoring and review of drug safety reports (PADERs, PSUR, PBRER, Addendum to Clinical Overview).❖ Preparation of Risk Management Plans and contributing in measuring the effectiveness of risk minimization measures.❖ Perform Signal detection and evaluation❖ Participate in cross-functional safety review teams for products in clinical development.❖ Respond to regulatory authority/healthcare professional queries for assigned products.❖ Review literature search results for ICSRs and articles for inclusion in safety reports.❖ Led the entire product lifecycle ensuring product safety for over 50 products.❖ Support assessment and implementation of regulatory intelligence findings that impact PV process.❖ Perform EU website monitoring for Glenmark products and in-licensing due diligence activities.❖ PV compliance and performance metrics presentation in QPPV meeting. ❖ Support audits, inspection and CAPA management.❖ Support product labelling activities❖ Provide technical guidance in the development and maintenance of procedural documentation. ❖ Mentoring of new team members joined in the team. Training of internal and external members involved in various PV functions. ❖ Support product labelling activities.❖ Provide technical guidance in the development and maintenance of procedural documentation. ❖ Mentoring of new team members joined in the team. Training of internal and external members involved in various PV functions. -
Specialist-Medical WritingImed Global Aug 2015 - Dec 2016Hyderabad Area, India𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 –❖ On deputation currently at Hyderabad office location of a top pharmaceutical firm in the world headquartered at Basel, Switzerland.❖ Authoring/Co-authoring along with global medical safety physicians, regulatory periodic safety reports (PSURs/PBRERs, Addendum statements) as per client portfolio: collecting, organizing, analyzing and presenting the data by means of specific templates and procedures.❖ Assist with cross functional expert teams to fulfill periodic safety report accountabilities (DRA, Clinical etc).❖ Quality review of PBRER and PADER within the dedicated timelines.
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Executive-Global PharmacovigilanceSun Pharmaceutical Industries Ltd.(Spil). Dec 2012 - Aug 2015Mumbai𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 –❖ Case Triage and Case Processing (Clinical ,spontaneous, Literature, Legal) in Oracle Argus Database along with MedDRA coding.❖ End-to-end support for Pharmacovigilance operations.❖ Quality review of ICSR's.❖ Reconciliation of ADR's.❖ Electronic submissions of ICSR's to regulatory authorities.❖ Performing daily Literature Search.❖ Data Migration to Argus Database.❖ Reviewing and Processing the Product Complaint Adverse Events, Literature cases.❖ Preparation periodic adverse drug reaction reports (PADERs).❖ Preparation of periodic safety update reports of DCGI, Health canada and ROW countries. ❖ Translation activity from French to English language of ANSM ASPRs and Literature ICSR’s.❖ Support the clinical research team with additional BA/BE activities.❖ Preparation of Health hazard assessment (HHA) with reference to product recall.❖ Assisted and responded to the queries in audit findings from EMEA observations.❖ An overview of signal detection activities.
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Senior Process AssociateTata Consultancy Services Mar 2011 - Dec 2012Mumbai Area, India𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 –❖ Competent Senior Drug safety associate in handling of case processing of the Serious adverse events (SAE).❖ Receipt of serious adverse event reports by e-mail or fax.❖ Case initiation: Triazing the cases, Identifying duplicate cases, enter basic data into database (Advent and ARISg).❖ Scientific assessment: Assess the expectedness of the adverse events in labeling documents (IB, CDS, SPC and USPI) for company products, create company opinion of causality.❖ SAE processing & tracking, using tracking safety database.❖ Have processed Spontaneous cases, Solicited cases, Clinical trial cases and Licensed party product cases.❖ Coding of events using MedDRA dictionary. Safety narrative writing and quality review of all SAEs for data completeness❖ Regulatory reporting to authorities, investigators and ethics committees. Ensure compliance with company policies, procedures and standards. ❖ Schedule follow up of cases, and generate queries to be sent to the investigator for completeness of report.❖ Maintain a high level of expertise with client projects and marketplace developments through participation in internal meetings, including project tracking and attendance at professional seminars and workshops -
Qa ExecutiveAccutest Research Laboratories (I) Pvt. Ltd. Apr 2008 - Mar 2011Khairne, Navi Mumbai𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 –❖ Worked as a GCP auditor as Executive involving Bioavailability and Bioequivalence trail.❖ In-process and retrospective audit prior to initiation and after the completion of clinical phase and pathological activities.❖ In-process auditing during blood sample collection and separation at respective time points.❖ In-process auditing during acceptance, Dispensing , Reconcillation , Transfer and Disposal of Investigational products.❖ Vendor audit of pathological labs.❖ Reviewing of Trail Master File (Pre-study, During study and post study ).❖ Reviewing of Screening forms prior to the initiation of study and CRF during and after completion of study including adverse events and serious adverse events.❖ Random checking of emergency medication kit and general code of conduct of participating volunteers in study.❖ Conduction of internal audit as per schedule in clinical and pathology department.❖ Preparation and review of standard operating procedures❖ Reviewing of Clinical Report and Statistical data.❖ Sponsor handling and Regulatory queries.❖ Actively involved in study close out procedures and various regulatory audits (US-FDA, WHO, CAP,ANVISA etc).❖ Reviewing of calibration of equipments.
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Research Quality AssociateCadila Pharmaceuticals Limited Jun 2007 - Jan 2008Ahmedabad𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 –❖ Worked as a GCP auditor as a Research Associate involving Bioavailability and Bioequivalence trail.❖ Preparation and review of Standard Operating procedures.❖ Review of Protocols prior to the initiation of the trials.❖ In process and retrospective audit of clinical and bioanalytical phase.❖ Carrying out retrospective audit after the end of the study of clinical, bioanalytical, and statistical data.❖ Member of validation team for IQ/OQ/PQ of instruments.❖ Handling document control and Archiving.❖ Handling Regulatory and sponsor queries.
Vikram Thakkar Education Details
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Dufle -
Alliance Francaise De HyderabadFrench Studies -
Alliance Francaise De Bombay
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M S University Of BarodaFirst Class
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Bachelor Of Pharmacy
Frequently Asked Questions about Vikram Thakkar
What company does Vikram Thakkar work for?
Vikram Thakkar works for Gsk
What is Vikram Thakkar's role at the current company?
Vikram Thakkar's current role is Success-oriented and Passionate Pharmacovigilance professional | Risk Management | Aggregate reports | Signal Management | Audits and Inspections | Team Management | Process Automation | Quality Assurance.
What schools did Vikram Thakkar attend?
Vikram Thakkar attended Le Mans Université, Alliance Francaise De Hyderabad, Alliance Francaise De Bombay, M S University Of Baroda, Swami Ramanand Teerth Marathwada University.
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Vikram Thakkar
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VIKRAM THAKKAR
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