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Pharmacy Office

Location:
Thane, Maharashtra, India
Posted:
May 31, 2018

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Resume:

SUSHILA SANJEEV ANKAM

Permanent Address – ***/ A*, Chandrakiran Society.Sector 5, Charkop.Kandivli (W), Mumbai -400067, India M - +91-902*-******

E – ac5o01@r.postjobfree.com

ACADEMIC BACKGROUND

Post-graduation Certified in Pharmacovigilance (2013 – 2014)

Academy for clinical excellence (ACE)

Bombay College of Pharmacy, University of Mumbai, Mumbai, India

Bachelor of Pharmacy (B. Pharm), Registered Pharmacist (2009 – 2013)

Bombay College of Pharmacy, University of Mumbai, Mumbai, India

LANGUAGE SPECIFIC AND PROFESSIONAL LEARNINGS

Advance Certificate in German (A2) (present)

Certificate in German (A1) (2016 – 2017)

Certified in LEAN and Six-Sigma (2015 – 2016)

EXPERIENCE (+ 3 YEARS)

Executive, Global Regulatory Operations

Teva Pharmaceuticals Limited (Mumbai Office) (Jun 2016 - Present)

oPublishing and submission management:

Working on Global Insight (GI) for Publishing of various regulatory submissions in electronic format (eCTD).

Expertise in publishing and submitting EU variations and renewals in eCTD and NeeS format, US PADER’s and Annual Reports with no quality issue.

Hands on experience on NeeS reformatting into eCTD, Document Level publishing (DLP) - includes document rendering, bookmarking, hyper-linking, compilation and creation of Table of Contents.

Validation Tools Used – Extedo EURS and Lorenz E-validator.

oRegistration Management of Submissions:

Maintaining Life-Cycle of Product through registration in Global Insight for Viewing.

Technical Associate, Global Regulatory Affairs (Oct 2015 – Jun 2016)

Genpact Pharmalink (Mumbai Office)

oPerforming and providing support for successful remediation for clients EudraVigilance Medicinal Product Dictionary (XEVMPD) records

Working on Art 57 QC Evaluation and XEVMPD data simultaneously

Providing expertise in process like submitting new product entity, remediation/nullification/withdrawing of existing product in eMPD

Submiting new dataset using current effective version of SmPC to Agency (EMA) with consideration of quality and compliance work with SmPCs and product dossiers

Major Achievements:

Working efficiently on recognized softwar eMPD Expert (Infotehna)

Analyzed and gave inputs on client’s current practices, processes, strategy, organizational structure and operations (LEAN Idea)

Global Bronze Award - Best Performer of the year (XEVMPD Project)

Consultant - Pharmacovigilance (Jun 2014 – Jul 2015)

Abbott India Limited (Mumbai Office)

oProvided efficient support to PV team for –

Safety Data Exchange Agreements (SDEAs)

Hands on drafting local SDEAs, ensuring contents of SDEA conform to Abbott standards and requirements, negotiating with the vendors and submitting to Global Pharmacovigilance on execution.

Adverse event Processing:-

Hands on processing all types of adverse event report which includes Spontaneous, Literature, License Partner & Pregnancy cases by proactively capturing the received ADE in respective forms.

Prepare safety data reports and promptly route the cases/ information within the timeline to license partners if applicable.

Product Complaints:-

Complete reconciliation between QA and PV at the affiliate, ensure that all complaints have been identified

Periodic Safety Update Reports (PSURs) :-

Knowledge on preparing of PSURs.

Compliance:-

Ensure a local tracking system for SDEA, Post- marketing ADRs i.e. ICSRs, Product complaints, Literature Screening in place.

Maintain monthly compliance metrics and monthly ICSR reconciliation with interacting departments and /or partner companies (if applicable) and act upon any discrepancies.

Miscellaneous:-

Experience in preparing SOPs/ Work instruction, tracking various types of information and metrics and ongoing QC of defined process steps.

Filing and archival of all PV documents timely.

Major Achievements:

Successfully executed SDEAs between Abbott India Limited and all vendors (TPMs, LL) with 100% compliance

Research oriented Trainee (Oct 2013 – Jun 2014)

Gattefosse India Private Limited & HEXA Analytical Labs (Mumbai Office)

oAcquired valuable knowledge and experience on designing formulation of cosmetic prototypes

Gained knowledge on Emulsifiers and Actives.

Formulated wide range of personal care products and evaluated the formulated products- Special focus on formulating projects of Skin Care, Hair Care, Men’s Care and Make-up prototypes.

Enhanced skills on calibration techniques and use of High Performance Liquid Chromatography, Gas Chromatography, Ultra- Violet Spectrophotometer, and Dissolution and disintegration apparatus.

Hands on experience on performing assay of various Active Pharmaceutical Ingredients and Excipients.

SKILL AND COMPETENCES

Expertise in various six sigma activities such as process gap analysis which helps in enhancing the quality of various regulatory activities.

Excellent Project management skills (LEAN) which abide to the timely submission of data to Regulatory Agency

Diversified skill set covers knowledge on development of Pharmacovigilance, Regulations of Pharmacovigilance in- USA, Europe, Japan, Australia & India, ICH guidelines, Benefit Risk assessment, Processing of Individual case safety reports(ICSRs), Literature screening, Signal Detection, Narrative writing, Preparation of PSURs and Handling various database- Oracle Argus & ARISg

Knowledge of regulatory requirements for ICH, GCP guidelines.

Analytical - Integrative and commendable experience on Chromatography, Mass spectroscopy, Validation, Stability Study

Computer skills: MS Word (Advanced), Excel (Advanced), PowerPoint (Advanced), Adobe Acrobat illustrator, Adobe Acrobat Professional (Advanced), Extended EudraVigilance Medicinal Product Dictionary (XEVMPD).

Good communication skills and insatiable capacity to learn new concepts and work methodologies; have an ability to make it a point to reach target goals and timelines.

SEMINARS ATTENDED

‘Regulatory Updates-Biowavers and Importance of BCS and TCS’ and ‘Continuous Manufacturing, Real Time Release & Regulatory Risk Classification System’ at SciTech - 2017

TEDx Gateway - 2014

‘Leaders of Tomorrow’ organized by Drug Information Association (DIA) at Bombay College of Pharmacy - 2013

Penetration enhancers and combating skin care at Bombay college of Pharmacy - 2012

‘Value added products’ development- THE 505(b) (2) ROUTE” - 2012

‘Radiopharmaceuticals’ organized by Indian Pharmaceutical Association (IPA) at Bombay College of Pharmacy - 2011

Clinical Research at Bombay College of Pharmacy - 2011

OTHER ACTIVITIES

1st Prize in poster presentation on LEAN 5S (Genpact India) - 2016

Participated in Global competition ‘Stepathalon’ – 2014

Volunteer:

GMA (Genius Mind Academy) - 2014 -2016

TFI (Teach For India)- 2013

NASEOH (National Society for Equal Opportunities for the Handicapped)- 2009



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