LINDA MASCARENHAS

E-mail ID: acsfq1@r.postjobfree.com

Skype ID: maslin5116

Contact No.: +971-*********

Visa status: Visit

Visa expiry: 01 Dec 2015

SUMMARY

Dynamic professional with more than 4.5 years of experience in Pharmacovigilance, Regulatory Affairs, Medical Writing and Regulatory Submissions in well-known pharmaceutical giants such as Novartis Healthcare and Novo Nordisk Global Safety Centre (GSC) in India, Denmark and Munich. Proficient in handling operations in compliance with nationally and internationally accepted regulatory requirements, organization policies and work instructions. Excellent interpersonal, communication and organizational skills with proven abilities in team management, customer relationship management and planning

CAREER HIGHLIGHTS

Medical Writing Regulatory Submissions Team management

Regulatory Affairs Documentation ICH-GCP guidelines

Vendor management Oncology & Endocrinology therapeutic areas

GMP & GVP Training junior medical writers/advisers

Preparation of Standard Operating Procedures Pharmacovigilance

EXPERIENCE

Safety Medical Advisor, Novo Nordisk GSC, India Mar 2015 to Aug 2015

Efficiently managed a team of junior medical writers and perform review of their documents

Worked in the Headquarters located in Copenhagen, Denmark so as to help the writers/advisers located there

Performed brand management activities for the products assigned

Performed pharmacovigilance (PV) activities such as case reporting, writing safety update reports based on these cases etc.

Authored as well as mentored the junior writers to manage critical regulatory submission related safety documents

Well informed about the safety aspects of the Novo Nordisk products assigned

Provided responses to any safety questions raised in connection with assessment reports

Oncology Submission Writer, Novartis Healthcare Pvt. Ltd., India May 2013 to Mar 2015

Authored, reviewed and independently managed high quality clinical and safety documents: non registration CSRs, DSURs and CTRDs

Worked as a core member of the Clinical Trial Team (CTT) in Headquarters located in Basel, Switzerland and also in Munich, Germany

Actively participated in planning of data analyses and presentation to be used in CSRs.

Documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines

Acted as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing

Supported the development of oncology department through participating in its initiatives and other related activities

Contributed to development of processes within oncology line function

Fostered cross-functional communication to optimize feed-back and input towards high quality documents

Conducted brand management activities for the upcoming and marketed products

Junior Medical Writer, Sciformix Technologies, India Jun 2012 to Feb 2013

Worked on drafting Investigator’s Brochures and certain sections of Clinical Study Reports

Worked on patient information leaflets, label updates and company core data sheets

Document Compilation Specialist, Tata Consultancy Services, India Apr 2011 to Jun 2012

Worked on submission and compilation of different modules for the annual reports such as IND/NDA/DSUR/BLA and ODAs

Worked on drafting patient narratives

ACAEDEMIC QUALIFICATIONS

2009-2011 – M.S in Clinical Research from Cranfield University, UK

2009-2010 – P.G. Diploma in Clinical Research Management, Institute of CR in India

2006-2009 – B.Sc. in Biotechnology from Mumbai University, Maharashtra

2004-2006 – H.S.C (Maharashtra Board), Royal College of Arts, Commerce and Science, Mira Road

2003-2004 – S.S.C (Maharashtra Board), Holy Cross Convent School, Mira Road

ADDITIONAL QUALIFICATIONS

Projects

Successfully submitted a thesis titled ‘Gestational Diabetes Mellitus and the Risk of Type 2 Diabetes Mellitus Associated with it’ to Cranfield University during the second year of M.S

Attended a ‘Root Cause Analysis’ training and submitted a project for the same.

Successfully completed an Inter-collegiate project titled ‘DNAse producing organisms’ during graduation (Biotechnology)

Successfully completed a project titled ‘Growth of Chiraag Computers’ during the PGDCRM course

Successfully completed ‘Basic Accountancy Course’ from Royal College, Mira Road (E)

Actively participated in a three day seminar on ‘Seven Habits of Highly Effective People’ conducted by Novartis Healthcare, Hyderabad

Attended a classroom session on ‘Lean Management’ conducted by Novo Nordisk GSC, Bangalore

Conferences

Attended a ‘National Level Conference on Nanotechnology’ held at Royal College, Mira Road (E)

Attended an ‘International Conference on Clinical Trials’ held at the Lalit Intercontinental, Andheri (E), organized by the CII

Strengths

Punctual

Well-organized

Team work

Adaptability / Flexibility

Hard working

ACHIEVEMENTS

Handled the honorable post of the General Secretary of Institute of Clinical Research (India), Mumbai campus

Have received certification in Advanced level of Communicating with Impact from Dale Carnegie Training institution

Have been awarded Star award for my exemplary contribution in drafting narratives and managing the vendors for submission related projects.

Have received a certification in Root Cause Analysis

Have been rewarded thrice with the Performance Linked Reward within TCS and also received TCS Gems for being an excellent performer

The story of my success in handling annual reports had been posted on TCS’s wellknown success portal ‘Know your Customer’ and was flashed to all the branches of TCS IT as well as Life Sciences

PERSONAL DETAILS

Date of birth: 05th January, 1989

Gender: Female

Nationality: Indian

Passport No.: H7069470

Marital Status: Single

Languages known: English, Hindi, Marathi and Konkani

Permanent Address: Al Barsha, Dubai, U.A.E

REFERENCES

To be furnished upon request

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