Drug safety

SWAPNIL BHIMRAO DHUMAL

**C, McGreevey Way, Boston, MA 02120 Cell no: 857-***-****

Email: ********.******@*****.***

https://www.linkedin.com/in/swapnil-dhumal-00010295

An enthusiastic Regulatory Affairs candidate with a strong science background majoring in pharmacy, determined to establish an exciting and rewarding career in Pharmaceutical industry.

PROFESSIONAL EXPERIENCE

Junior Safety Data Analyst Mar 2015 – Aug 2015

Sciformix, Pune, India

Key responsibilities:

Implement consistent and efficient quality process to meet timelines and deliverables according to requirements and standard operating procedures.

Ensure compliance of operations with governing regulatory requirements.

Create, maintain and assume accountability for a culture of high customer service.

Execute drug safety data management processes - a combination of call intake, case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up.

Perform any other support activities as assigned - tracking the various type of information and metrics, ongoing QC of defined process steps, training and reconciliation of data from multiple sources including literature search.

Assume responsibility for the quality of data processed.

Clinical Pharmacist Jun 2014 - May 2015

Bharati Vidyapeeth Hospital and research Centre, India

Participation in clinical ward rounds & clinical discussion on drug therapy

Providing Drug information, screening ADRs, patient counselling, analyzing drug usage patterns, conducting patient history interviews.

Preparation, review, follow-up, and reporting of Adverse Events (AE)/Severe Adverse Events (SAE).

Clinical Trial Intern (Paediatric Vaccine Trials) Aug 2014 - Nov 2014

Bharati Vidyapeeth Hospital and research Centre, India

Abstracting, assembling and organizing research data while monitoring the clinical course of patients entered onto research protocols.

Managing trial site, protocol development focusing on data collection.

Reports on individual patient in response to investigator requests & modifying clinical work flow.

Active participant in audits, documentation in charge for GDP compliance.

Submitting research data in a timely manner to external affiliates, agencies, sponsors & IRBs as needed.

ACADEMIC EXCELLENCE

MS in regulatory affairs for Drugs, Biologics and Medical Devices Sep 2015 - Present

Northeastern University

Doctor of pharmacy (Pharm.D) Aug 2012 - Jun 2014

Bharati Vidyapeeth Deemed University, Pune, India

KEY SKILLS AND STRENGTHS

Excellent knowledge in Drug and Medical device regulatory submissions.

Updated on FDA, Health Canada, EU regulations & requirements.

Adapt in creating unique approaches, work plans driving business growth.

Accustomed to work with project teams, providing research and advice on Federal law compliance.

Proven communication, summarizing and problem solving skills.

Excellent knowledge of ISO, ANSI/AAMI, FDA guidance documents for regulatory submissions..

Excellent skills in preparation, Reviewing label & understanding significance of symbols.

Familiar with concepts of Drafting SOPs and crafting instructions to follow.

Clinical experience in framing, conducting, analysing Pre-clinical & Clinical studies.

Active participant with ability to manage work stress in all situations

TECHNICAL ASSETS

Narrative writing in Pharmacovigilance

ICH Guidelines for Pharmacovigilance

PSUR, ICSR, DSUR.

Methods of Signal Detection

Causality assessment in pharmacovigilance

MEDRA

DISSERTATION

Research project Nov 2013 - May 2014

EVALUATION OF CLINICAL PATTERN, SEVERITY AND MANAGEMENT OF POISONING: A retrospective study

A 6 months retrospective study was conducted on patients admitted with toxidrome to evaluate the clinical pattern, severity and management of poisoning.

ADDITIONAL WORK HISTORY

Peer Teaching

Bharati Vidyapeeth deemed University Jun 2013 - Jun 2015

Teaching assistantship under professors dealing courses- Clinical Research, Clinical Pharmacy & Hospital Pharmacy.

TRAINING/INFORMATIVE SESSIONS

Workshops on overview of clinical operations data management and pharmacovigilance, MEDRA

IACP workshop-2014

Pharmacovigilance: Collaborative Role of Industry and Hospital in Patient Safety.

AICTE Sponsored Quality Improvement Programme on Pharmacotherapy review for Advanced Clinical Pharmacy Practice

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