Safety Management

Pavitra Pradeep Patil CONTACT

*, ***** ***** *****, ************, Tel: +91-986*******

Pune, Maharashtra, India e-mail: p ****.*******@*****.***

SUMMARY

Drug Safety Officer more than 6 years of experience in Pharmacovigilance activities in Pharma

industry.

OBJECTIVE

It would be my earnest attempt to effectively use the knowledge, experience and skill in order to

achieve my ultimate goal of self-development along with that of the company.

PROFESSIONAL EXPERIENCE

Presently Working with:

Pfizer LTD.

Working for Pfizer India Ltd. for Drug Safety operations of all marketed drugs and for clinical trials

done in India and India Region from August 2008 till date.

Previous Job experience:

CLININVENT RESEARCH PVT LTD.

Worked as a trainee in the Medical & Research Division of Pfizer Limited. Assisted in preparation of

Clinical Trial Applications for DCG(I) approval. Assisted in preparation of Site Master Files/ Trial

Master Files for site initiation.

EDUCATION

Post-graduate diploma in medical law and ethics, National Law School of India University,

Bangalore (2015)

Master of Science in Clinical Research from Cranfield University, United Kingdom (Jun 2008)

Post Graduation diploma in Pharmaceutical Management, ICRI, Mumbai, India. (Jun 2007)

Bachelor of Science in Life Science and Biochemistry, Mumbai University, India (Jun 2006)

Job Responsibilities from current to previous:

Pharmacovigilance: Reporting as a Drug Safety Officer.

Collection and Triaging of AE reports received from clinical trials and post marketing activities.

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Perform Data entry or case processing of cases in Argus

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Perform peer review, quality review of the cases as per assigned role

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Report SAEs / SUSARs to appropriate Regulatory Authorities and participating Investigators and to

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ensure compliance with the timelines.

Provide input into responses to inquiries from regulatory authorities or healthcare professionals on

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safety issues.

Maintain and update safety files

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e-archival of all the safety documents (e.g. CIOMS, Investigator acknowledgements etc.)

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Resolve data management queries and coordinate with Clinical team for AE-SAE reconciliation

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Interfaces with clinical operations team and Alliance Partner for safety matters including follow-up

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on events of interest, resolution of site queries regarding serious adverse events and quality review

of narratives.

Updated on 14th August 2012 1 of 3

Pavitra Pradeep Patil CONTACT

8, Butte Patil Pride, Chandannagar, Tel: +91-986*******

Pune, Maharashtra, India e-mail: p ****.*******@*****.***

Provide input to detailed review of events of interest for key data extraction for analysis purposes

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including the SUSAR and other ad hoc analyses.

Assisting in generation and review of SOPs and Wls

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Comply with PV regulations and Company procedures

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Assisted in generating risk management activities, including risk minimization plans, risk

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mitigation plans, business continuity plans.

Contribute towards continued improvement of safety systems and processes

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Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play

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a leadership role as a subject matter expert and/or project lead across all WSRO DSU

Promote/participate, as appropriate, in local, internal and external safety activities

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Mentor new safety colleagues for all safety related activities.

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Analyze and monitor activities, define and implement corrective actions, where applicable.

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Quality and compliance Experience in Pharmacovigilance:

• Assisted with in corporate audit activities

• Conducted Quality Review of marketed programs on a Monthly basis for India and India Region

• Supported the team in aligning the marketed programs and Safety languages in compliance with

company policy.

• Assisted in 3 Audits for Drafting PV audit responses and CAPAs

• Conducted follow-up to verify that CAPA have been implemented as applicable in the team

• Conducted the Quality Review of Professional records to ensure compliance with inspection

readiness SOP for my function

• Assisted to create/amend local work instructions and supporting document.

• Actively working on contract review for safety language and liaise with stakeholder for the same

• Active involvement in pre and post action arising from PV audits and inspections

Other experience: Handled responsibilities of Country Safety lead for around 6 months.

• Efficiently managed resources in the Drug Safety Unit (DSU)

• Ensured fulfilling of drug safety-related obligations for the country

• Participated in country activities as DSU point of contact for Pharmacovigilance Business Line

• Ensured timely and accurate handling of individual and aggregate reports to meet corporate and

regulatory reporting requirements for the country

• Acted as country’s point contact for Safety, internally and externally

• Monitored and managed training of DSU, and ensure coaching and mentoring

• Developed and maintained knowledge of applicable SOPs, CP and other procedural documentation

• Took responsibility for implementing the corrective actions resulting from timeliness or quality

issues associated with safety-related activities for the country

• Mentored colleagues on the effective use of the corporate safety database

Updated on 14th August 2012 2 of 3

Pavitra Pradeep Patil CONTACT

8, Butte Patil Pride, Chandannagar, Tel: +91-986*******

Pune, Maharashtra, India e-mail: p ****.*******@*****.***

Regulatory Affairs experience:

• Pharmacovigilance and Labeling operations for all marketed products and clinical trials done by

Pfizer in India and India Region

• Assisted in Clinical Trial Applications for approval from Health Authority.

• Assisted in regulatory Query resolution arising from regulators

• Provide support as required for regulatory authority inspections, audits and for product project

activities.

Previous Job experience: Reporting as Intern (trainee)

• Learnt the working of Medical Research Department.

• Preparing Clinical Trial Applications for approval from DCGI.

• Preparing Site Master Files/ Trial Master Files for site initiation.

• Corporate clinical trial registry.

• Performing all the documentation work according to SOPs.

• Archiving documents.

• Clinical monitoring overview

TECHNICAL SKILLS:

• Understanding and ability to use computer technology, management of relational database systems.

• Working knowledge of pharmacovigilance concepts.

• Knowledge of national PV regulations.

ACCOMPLISHMENTS AT PFIZER

• Was invited as guest lecturer on Pharmacovigilance in India, KC College, Sep2011.

• Awarded as Most Valued colleague in Safety 2010

• Yellow belt certified Sep2010

• Was invited as Speaker on Regulatory Affairs Historical development of regulatory bodies. Pharma

regulatory affairs: Objectives & issues" and "indian regulations; KEM Hospital. Mar2010.

PROJECT WORKED ON:

• Hinduja hospital, Mumbai: Conducted an interventional study with two groups having same

sample size: (n = 28) with primary aim: to assess the effect of CP (care pathways) on pain relief and

patient satisfaction after Total Knee Arthroplasty. Secondary objectives were to evaluate the

satisfaction with the information provided and whether the CP helped to reduce the fear and the

queries of patients undergoing the surgery.

PUBLICATION:

• Full text article: The impact of arthroplasty care pathway in improving pain recovery and patient

satisfaction in patients undergoing knee arthroplasty- Publication in progress.

I hereby declare that all the information provided above is true to my knowledge.

Place: Mumbai Pavitra Pradeep Patil

Updated on 14th August 2012 3 of 3

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