Dr. Namrata Singh

adhzsv@r.postjobfree.com

+91-998*******

Address: ****/***** *- ******, ****** Anthurium, L.B.S. Marg, Opp Veena Nagar, Mulund West, Mumbai-400080.

Career objective

To pursue a challenging career in the field of pharmacovigilance & clinical research and to participate in the growth and profit of the professionally managed organization as well as add value through my commitment and hard work.

Professional experience

•Team Lead at Tata Consultancy Services Ltd, Mumbai: 2019 – till date

•ICSR Technical Trainer and Mentor: 2014 – 2018.

•Pharmacovigilance Scientist: Jul-2012 - 2014

Working for Switzerland based pharma client in Drug Safety department. Overall accountability of day to day case processing activities including service level agreement monitoring and focusing on compliance. Managing workflow with regards to triaging, distribution, and completion of cases as per SOP/LP and regulatory timeline. Managing RCA analysis and implementation of CAPA with compliance monitoring. Experience of leading training team with training coordinating activities experience for more than 200 new joiners. Managed and handled system upgrade roll out activities.

Responsibilities:

Team lead and Work-flow Manager

•Knowledge of global pharmacovigilance regulatory obligations.

•Overall accountability of day to day case processing activities including service level agreement monitoring and focusing on compliance.

•Ensuring adequate resources availability.

•Ensure compliance to SOP’s and other process related documentation across the function.

•Ensure project are completed within agreed timelines.

•Managing RCA analysis and implementation of CAPA with compliance monitoring.

•Managing workflow with regards to triaging, distribution, and completion of cases as per SOP/LP and regulatory timeline

•Process/workflow co-ordination.

•Ability to effectively delegate workload.

•Identify poor utilization and resource re-alignments.

•Good negotiating and influencing skills.

•Promotes a positive, collaborative work environment.

•Manage regular communication with team members and also have continuous feedback sessions with the idea of scope in improvement.

•Rewarding, appreciating associates and conduct performance appraisals for the team.

•Offering any weak area and offer mentoring who need it.

•Resolves disputes, deals with associates’ error and feedbacks.

•Ensure all required documentations are completed with audit readiness.

ICSR Technical Trainer

•Conducting trainings for new associates and for existing staff.

•Conducting refresher trainings.

•Delivered training module effectively and had checked for training effectiveness.

•Coordinating and coaching new associates on quality towards sign off.

•Developed client training modules.

•Arranging sign-off meetings with clients.

•Attending client calls on training and reconciliations, trainer forum etc.

•Client interactions.

•Proactively providing feedback about incomplete, inaccurate, or missing training material to client.

•Assisting client in preparation, delivery and maintenance of training programs.

•Assisting in PV project, taking ownership of project as needed.

•Maintaining all records pertaining to the team.

•Ensuring individuals are audit and inspection ready.

Mentor

•Responsible for identifying and implementing continuous improvement activities.

•Accountable for establishing and implementing best practices sharing in pharmacovigilance activities.

•Assisting in relevant Drug Safety projects and taking ownership for assigned processes and projects (as needed).

•Identifying lack of understanding of individuals in training sessions and address identified needs

•Discussing associates understanding with mentors and managers as required.

•Responsible for providing guidance and support to new mentors/trainers.

•Ensuring sign off documentation is in place and accurately reflects the individuals training

•Proving mentoring to new staff to include tasks such as:

•Guiding and mentoring new associates on drug safety activities relating to ICSR processing.

•Assigning cases for processing to associates in mentoring phase.

•Resolving queries, identifying areas of concern, ensuring that outstanding training needs are addressed, and timely feedback is provided for associates in mentoring

•Maintaining mentoring spreadsheets (as applicable) for each associate through to sign off approval

•Conducting and facilitating the sign off review meetings

•Ensuring that the associate maintains up to date training records during their mentoring period

•Performing Quality Review for Drug Safety (as appropriate).

•Checking cases of mentees on the Safety Database for accuracy in key fields and making any amendments as necessary

•Providing feedback on errors to individual associates as necessary

•Identifying refresher training required by associates and highlight training needs or QR trends to Drug Safety Management at TCS

•Participating in quality and compliance meetings as required.

•Acting as a Subject Matter Expert for the Drug Safety group.

•Approving mentees items in quality review to be sent to pre-archive.

•Coordinating logical and physician deletion activities to ensure that all mentees due cases within this workflow are identified and closed.

•Answering queries from PV Scientists and, when in doubt, reviewing and ensuring appropriate queries are sent to Client, and responses are received in a timely manner.

•Involvement in development and implementation of corrective and preventative actions as requested.

Drug Safety Associate (Case Processing)

•Accountable for handling ICSRs received via data exchange systems, triaging, performing duplicate searches and disposition of valid items into ARISg from IRT for further processing in ARISg.

•Responsible for identifying duplicate/invalid ICSRs in ARIS and handling as per relevant SOP.

•Quality review of latest received date (LRD) of incoming licensee cases with reference to SDEA and PV agreements.

•Acknowledging receipt of ICSRs to sender within the timelines documented in the relevant SOP.

•Accountable for sending queries for clarity associated with incoming information if required.

•Accountable for handling ICSRs disposition of valid items into ARIS from IRT for further processing in ARISg (case initiations)

•Accountable for performing accurate data capture for individual case safety reports which can be spontaneous, clinical and non-interventional study/ program.

•Knowledge of various type of case reports: CIOMS, MedWatch reports, Rave reporting system etc.

•Perform data entry for processing and coding relevant medical terminology, writing appropriate and clinically coherent narratives, performing quality check, assisting with reconciliation and medical review teams.

•Sending MedDRA requests as needed and discussing with operation physician team regarding the amendment/split and raising queries regarding the events.

•Accountable for performing appropriate clinical assessments (including assessments of seriousness, labeling, and company causality for each adverse event).

•Responsible for identifying duplicate/invalid ICSRs (clinical, spontaneous and non-interventional study/program) in ARISg and handling as per relevant SOP.

•Identifying potential Day 7 and Day 15 timeline SUSAR’s cases and process them on priority.

•Raising queries to Safety Responsible personnel.

•Responsible for generating and forwarding appropriate queries and requests for missing information and for clarification or follow up information.

•Assuring compliance with the use of safety database through reference of latest SOPs and relevant manuals.

•Assuring and maintenance compliance with regulatory and local/ global SOP timelines using proactive workflow management.

•Developing and maintaining knowledge of the appropriate disease biology areas.

Achievements in organization

•Appreciated by client for maintaining best quality and providing innovative ideas for process improvement and excellent quality in case processing.

•Appreciated by client efforts and timely co-ordination with all stakeholders and leading a team to who have successfully completed a challenging task.

•Suggested and implemented common templates for queries to reduce the communication delay.

•Successfully handled end to end Swiss HA and CTV CAPA projects.

•Participated successfully in various internal as well as external audits.

•Received “Star performer award”,” Group performance award”, “Performance linked reward”, “Service and commitment award”.

Technical skills

•Database : ARISg Safety Database v 6.3, 6.6 and 7.4

•Office Tools : MS Word, Excel, Power Point

Organizational skills

•Strong interpersonal and presentation skills.

•Good organizational and problem-solving efficiency.

•Excellent written and verbal communication skills.

•Knowledge of global pharmacovigilance regulatory obligations.

Key strengths

•Associate management skill, effective leadership and influencing skill.

•Ability to take ownership for assigned project.

•Ability to work under pressure and convey a sense of urgency.

•Pro-active approach to assigned tasks.

•Excellent communication skills, both written and verbal.

•Determination towards work.

•Positive attitude towards life.

•Capacity to deal with stress.

•Willing to share knowledge.

•Promotes a positive, collaborative work environment.

Previous Work Experience

•Worked at Bombay Spine Centre, Unnati Hospital as Clinico-surgical Assistant

From Jan 2007 to Jun 2012. (Performing clinical evaluation and assessment of OPD patient, case taking, indoor patient medical management, assisting in surgeries, post-operative patient management and care, post-operative notes writing and records keeping, billing issues handling, general hospital administration, post-operative follow-up review, patient query resolving, counseling of patients and advising patients on medical and life management.

Educational qualifications

•M.D. Homoeopathic Pharmacy (2007-2010) from Foster Development’s Homoeopathic Medical College, Aurangabad, Maharashtra.

•B.H.M.S (2002-2006) from Smt. Chandaben M Patel Homoeopathic Medical College, Vile Parle (West), Mumbai, Maharashtra.

•H.S.C (2001) from V.K.K. Krishna Menon Jr. College, Mumbai, Maharashtra.

•S.S.C (1999) from Mulund High School, Mumbai, Maharashtra.

Personal details

Date of Birth : 22-Jun-1983

Gender : Female

Marital Status : Married

Husband’s Name : Dr. Rishikesh Chandane

Children : 1 Daughter – Akeera Chandane (5 yrs)

Nationality : Indian

Languages Known : English, Hindi and Marathi

Declaration

I hereby declare that all information furnished above is truthful and precise to the best of my knowledge.

Dr. Namrata Singh

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