Resume

Dr. Seemant Handa, MD

***, ** **** ****** **********

Madinaguda, Hyderabad - 500049

Phone: +91-987*******

Email: adlg1q@r.postjobfree.com

Objective

To have a job that would enable me to use my talent and skills as well as contribute to organization's goals and which would provide excellent opportunities for career advancement and personal growth.

Professional Experience

Position

Duration

Institution

Intern

1 year

Hindu Rao Hospital, Delhi

Resident Medical Officer

1 year

Handa Nursing Home, Meerut

Resident (Pharmacology)

3 years

Santosh Medical College, Ghaziabad

Senior Resident (Pharmacology)

4 Months

(July 2012 – October 2012)

Rama Medical College & Research Centre, Ghaziabad

Senior Research Scientist, MACR, Pharmacovigilance

November 2012 - December 2015

Sun Pharmaceutical Industries Ltd., Gurgaon.

Assistant Manager [Safety Surveillance Physician – Pharmacovigilance (worked for AstraZeneca)].

December 2015 – July 2017

Tata Consultancy Services, Mumbai

Deputy Manager (Drug Safety Physician - Pharmacovigilance)

July 2017 - 01 Oct 2018

Mylan Pharmaceutical Pvt. Ltd., Hyderabad

Senior Safety Signal Expert

08 Oct 2018 till date

Novartis Healthcare Private Limited, Hyderabad

Current Job Responsibilities

Main Accountabilities:

Signal Detection:

Performing signal triage and detection activities including searches in external drug safety databases (such as FAERS/Vigibase) for signal confirmation.

Performing single case medical review in the safety database or on line listings.

Screening of EUDRAVIGILANCE database for detection, validation and assessment of Safety Signals.

Acting as a deputy for existing PVLs assuming full responsibility during the deputation period as required.

Contributing to the development and updates of safety sections of Core Data Sheets and associated documents such as clinical overview as required.

Playing an active role in Safety Management Team (SMT) meetings and deputizing for the PVL as required.

Chairing Safety Processing Team (SPT) as required.

Playing an active role presentation to SIGDET meetings including preparatory activities.

Providing support as required for licensing activities, regulatory authority inspections/audits and for project/product recall activities as required.

Mentoring newly recruited colleagues by supporting their integration into the PVE role.

Compliance with Internal and External regulations and procedures

High level of independence

Previous Job Profile

Medical review of signal reports including detection, validation and assessment from company designated safety database.

Screening of EUDRAVIGILANCE database for detection, validation and assessment of safety signals.

Medical evaluation of Potential signals received from various stakeholders including product safety, manufacturing sites or literature monitor team.

Preparing Medical Risk Assessments (MRAs) for quality related issues.

Assisting in Periodic Safety Update Reports (PSURs) and Addendum to Clinical Overview (ACO) related activities (including but not limited to report writing & medical review, handling of requests received from Central & Local Regulatory Affairs and PV departments) within respect of timelines and any other related task.

Preparing responses to REGULATORY AUTHORITY questions related to safety issues and conducts medical review

Writing & update of Standard Operating Procedures (SOP)

Liaising with global, regional and local Regulatory, quality, medical affairs, clinical research, commercial & PV Departments, affiliated companies and Mylan drug safety in performance of above mentioned tasks.

Ensuring compliance with global and local procedural documents and local implementation of AstraZeneca (AZ) and TCS Patient Safety objectives, policies, procedures and processes.

Maintaining up to date knowledge of the AZ products assigned with focus on the safety perspective. This includes but is not limited to pharmacology, indications, safety and efficacy aspects and could potentially include clinical studies and epidemiological analyses.

Review of AZ surveillance strategy document and provide written confirmation verifying its understanding of changes.

Review of aggregate case reports from AZ designated safety database using relevant IS systems.

Review and assessing literature bulletins and published meeting abstracts in accordance with AZ’s search strategy, using relevant IS systems.

Identifying safety signals from routine review of cumulative safety data and conduct initial evaluation of those signals and document outcome according to AZ specified criteria and requirements.

Notifying AZ surveillance team of any safety signal that it has detected that may require urgent evaluation and action.

Conducting further evaluation of safety signal as required by AZ, using AZ safety designated database and or the published literature.

Preparing, summarizing, evaluating and documenting routine pre-SERM (Safety Evaluation Review Meeting) safety outputs from AZ dedicated safety database, dedicated external databases (FDA AERS, WHO Vigibase) and the published literature.

Participating in routine and ad-hoc team and project related meetings between AZ and TCS like Handover Meeting, Surveillance Meeting, and Safety Management Team Meeting.

Preparing training material, conduct and assess periodic and need based trainings as and when required.

Providing ongoing training on the updated surveillance strategy document, routine signal management requirements, product safety profiles and updated safety signal detection criteria for new hires.

Participating in conducting gap analysis and identify the remedial actions for the improvement of quality of deliverables as and when required.

Providing regular work update to lead-safety surveillance.

Medical Review of ICHs for inclusion in the narrative discussion of 15 day alert reports submitted to FDA

Quality review and finalization of Individual Case Histories for inclusion in the Periodic Adverse Drug Experience Reports (PADERs).

Managing Work Grids.

Making work plan for the team members.

Ensuring Compliance to Applicable Regulations, Guidelines and Company’s Procedural documents.

Giving Presentations on various aspects of Pharmacovigilance.

Attending/Imparting Trainings on various aspects of Pharmacovigilance.

Software/Database/Operating System Exposure

• MS Office

• EUDRAVIGILANCE, ARGUS, EMPIRICA, SAPPHIRE

• Windows XP & Windows 7

Education

MD (Pharmacology)

Santosh Medical College, Ghaziabad 2009 to 2012

MD (Physician)

Kuban State Medical University Krasnodar, Russia 2000 to 2006

Postgraduate Teaching Experience

Teaching assignments to undergraduate students of MBBS, BDS, Bachelor of Physiotherapy (BPT) and Nursing (practical and theory)

MD Thesis Work

Antimicrobial Drug Prescribing Patterns for Surgical Prophylaxis and the Incidence of Surgical Site Infection. A Prospective Study Conducted in a Tertiary Level Hospital in Ghaziabad

Seminars/Journal Clubs Delivered

Phases of Drug Discovery

Phase IV Clinical Trials - Pharmacovigilance

Basic Pharmacology versus Clinical Pharmacology

Receptors involved in Drug Action

Animals used in Experimental Pharmacology

Recent advances in the treatment of Alzheimer’s disease

Screening methods of Antihypertensive Agents

Screening methods of Antidiabetic Agents

A Comparative evaluation of price & quality of some branded versus non-braded generic medicines of same manufacturer in India

Conferences and Symposia Attended

WHO sponsored conference on “Pediatric Pharmacology”, ASCOMS, Jammu

8th Annual Conference of Indian Association of Medical Microbiologists, U.P. Chapter, Feb. 2012

Indian Pharma Summit, FICCI Auditorium, New Delhi. Nov. 2011

Seminar and Workshop on Functioning of various “INCO” Laboratory equipments and machines. Ambala. Apr. 2011

National Workshop on Clinical Trial Operation & Management, New Delhi. Mar. 2011

International Conference and CME cum Workshop on Pharmacovigilance Systems and Rational Use of Medicines: An Integrated Approach. LHMC. New Delhi. Nov. 2010

CME Alternatives to Animals in Medical Education (AAME). Feb. 2010

National Conference of Indian Pharmacological Society, Kolkata 2010

9th Annual Conference of Society of Pharmacovigilance. Nov. 2009

Publications

Abstracts

Rationality of Surgical Antimicrobial Prophylaxis - A prospective study in a tertiary care hospital in Ghaziabad. Proceedings of 8th Annual Conference of Indian Association of Medical Microbiologists, U.P. Chapter, 11th February 2012

Rationality Analysis of Antimicrobial Drug Prescriptions for Surgical Prophylaxis - A prospective study in a tertiary care hospital in Ghaziabad. Proceedings of 4th Annual Conference of Indian Association of Medical Microbiologists, Delhi Chapter, 25th February 2012

Manuscript

Handa S., Ashutosh R., Chopra V.S. (2012) Rationality of Antimicrobial Drug Prescriptions for Surgical Prophylaxis – A Study at Tertiary Care Hospital in Ghaziabad. (Submitted for publication to Indian Journal of Physiology and Pharmacology)

Certifications

MCI Registration Number MCI/08-33011

Advance Certificate Program in Project Management

Catalyst Clinical Services 2008

Diploma in Russian Language

Kuban State Polytechnic University Krasnodar, Russia 1999 – 2000

Professional Memberships

Member of Medical Council of India

Member of Delhi Medical Council

Member of Indian Pharmacological Society

Community Activities

Participated in Pulse Polio Campaign Organized by M.C.D.

Volunteered in a Health Camp organized by an NGO “SWARAJ” Social Welfare Society

Skills

Critical thinking in appropriate decision making

High level of interpersonal and public speaking skills

Excellent communication skills, speak to individuals and groups to communicate effectively and present ideas imaginatively

Designing and planning skills, setting priorities and managing time efficiently

Languages: Hindi, English, Punjabi, Russian

Computer Skills: Word, PowerPoint, Excel

References

Available on request.

Contact this candidate