Manager Management

M. Lakshmi Sowjanya

Mobile: 91-995*******

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

OBJECTIVE

To achieve excellence in the field of Regulatory Affairs and

Pharmacovigilance domain in a professionally challenging and motivating

environment of Pharmaceuticals, Biotechnology, CRO, IT product & services

and associated healthcare sectors to add a value to my expertise in a

strategic leadership role to drive, develop & achieve excellence for

sustainable growth of myself and my organization.

DOMAIN SKILLS

Regulatory Affairs & Pharmacovigilance Domain Awareness

. Regulatory affairs and Pharmacovigilance Domain awareness.

. Regulatory submissions to US, EU and ROW market

. Review of documents received from QA, R&D, AR&D and other department with

respect to regulatory submission.

. Prepared & reviewed annual reports, 15 days alert report & Periodic

safety reports

. Handling queries of Authorities & submission of responses related to

queries.

. Knowledge of drug development (Phase I - IV) of clinical trial.

. Pharmacovigilance in India.

. Adverse events and its reporting standards.

. Adverse event reporting forms.

. Expedited case and reporting timelines.

. Hands on experience on Oracle ARGUS Safety 6.0 database - Data Entry,

Case Processing, MeDRA coding, SAE Narrative writing.

Pharmacovigilance expertise

I am Trained Professional in Pharmacovigilance with Oracle Argus Safety

Database, MedDRA and WHO drug dictionaries coding with practical experience

in Data Entry, Case Processing, MeDRA coding, SAE Narrative writing.

Professional Skills and Strengths:

. Sound knowledge on detection, assessment, management, reporting,

monitoring, prevention and documentation of ADR

. Strong working Knowledge on Oracle ARGUS Safety database, MedDRA, WHO-

DRUG dictionaries.

. Proficiency in understanding and interpreting Safety Reports

. Plan, organize, and manage daily work to meet service level timelines and

deliverables.

. Good communication and written skills

. Belief in consultative style of functioning and able to work under stress

conditions.

. Self motivated hard working and adaptable.

. Quick to learn new things

PROFESSIONAL EXPERIENCE:

Pharmacovigilance Trainee:

Gratisol Labs, Hyderabad.

I have undergone rigorous training in Oracle Argus Safety Database 6.0,

with Pharmacovigilance foundation.

Roles & Responsibilities:

. Case Assessment

. Duplicate Check and case initiation

. MeDRA coding

. WHO DD coding

. SAE Narrative writing

. Expectedness or Listedness of the event.

Clinasia Labs July 2011 to till

date

Manager - Regulatory Affairs

Roles & Responsibilities:

> Client interfacing and pre-sales support (Electronic Submissions -

IND/NDA/ANDA/BLA/510K, Structured Product Labeling - R3/R4/R5, Clinical

Trial Disclosure/Registration for USA and Europe)

. Participate in client meetings at within India or USA or other Countries.

. Client requirements gathering and analysis

. Client presentations

. Build Product Competitive Analysis by comparing the product across the

competitive offerings

. Product-based case study building and demonstrations

. White paper writing and publishing / presenting

. Attending at conference/seminars

> Client Delivery Planning and Management (Electronic Submissions -

IND/NDA/ANDA/BLA/510K, Structured Product Labeling - R3/R4/R5, Clinical

Trial Disclosure/Registration for USA and Europe)

. Electronic or Paper submission activities using software or outsourced

services.

. Structured Product Labeling using software or outsourced services.

. Clinical Trial Disclosure and Registration Management using software or

outsourced services

> Product Management Support

. Identifying requirements

. Building functional specifications

. Improve and maintain sustainable offerings of the product by continuously

enhancing the product features based on competitive intelligence, and

market requirements.

. Communicating with product development team and explaining the functional

specifications

. Product Testing and Validation

. Internal quality and compliance management for clinical services delivery

> Building and managing SOPs

. Coordinating with the quality manager in conducting SOP training and

internal Audits

ORCHID CHEMICALS & PHARMACEUTICALS LIMITED May 2009 - July

2011

Assistant Manager - Regulatory Affairs Department (US Market)

Roles & Responsibilities:

. Undertook review of documents & compilation of ANDA in CTD format while

submitting to FDA.

. Review of documents received from QA, R&D, AR&D and other department with

respect to correctness and compliance for regulatory submission.

. Review and approve change controls, deviations and incidents and provide

guidance.

. Prepared & reviewed annual reports, 15 days alert report & Periodic

safety reports

. Managed deficiencies (Chemistry, Labeling, Microbiology and

Bioequivalence) and handled amendments & supplements

. Monitored NLM/FDA/Innovator websites for initiating and for constant

update of PIL's regularly.

. Do thorough review of dossiers and deficiency response as per current

regulatory guidance documents.

. Regular monitored of Regulatory updates and Pharmacopeial updates.

. Management of team, identification/retention of talents.

. Provide regulatory strategy in order to achieve best preparation and

approval time for regulatory dossiers.

ZENOTECH LABORATORIES LIMITED Dec 2007 -

May 2009

Junior Manager - Regulatory Affairs Department (US Market)

Roles & Responsibilities:

. Undertook review of documents & compilation of ANDA in CTD format while

submitting to FDA.

. Review of documents received from QA, R&D, AR&D and other department with

respect to correctness and compliance for regulatory submission.

. Prepared & reviewed annual reports, 15 days alert report & Periodic

safety reports

. Managed deficiencies (Chemistry, Labeling, Microbiology and

Bioequivalence) and handled amendments & supplements

. Monitored NLM/FDA/Innovator websites for initiating and for constant

update of PIL's regularly.

. Do thorough review of dossiers and deficiency response as per current

regulatory guidance documents related to ROW (Rest of the World).

. Provide regulatory strategy in order to achieve best preparation and

approval time for regulatory dossiers.

DR REDDY'S LABORATORIES LIMITED May 2006 - Dec 2007

Senior Executive in Regulatory Affairs Department (US Market)

Roles & Responsibilities:

. Write high-quality CMC documentation for submission assuring technical

congruency and regulatory compliance meeting agreed upon timelines and e-

publishing requirements.

. Review of documents received from QA, R&D, AR&D and other department with

respect to correctness and compliance for regulatory submission.

. Planning of regulatory filings (ANDA) in coordination with other

departments and within the team.

. Ensure regulatory submissions are adequate and error free and are made in

time with relevant regulatory agencies.

. Review and approve change controls, deviations and incidents and provide

guidance.

. Review and approve process and cost improvement proposal and provide

guidance.

. Review and coordinate with the stake holder for pharmacopoeial updates

that appear in the USP Forum and Supplements and ensure it's on time

implementation.

. Responsible for Life cycle management of the approved drug product.

. Monitoring RLD labeling changes and updating commercialized product

labeling as per guidance.

GLAND PHARMA LIMITED May 2003 - May 2006

Executive in Regulatory Affairs Department

Roles & Responsibilities:

. Review and compilation of dossiers to ROW (Rest of the world) like Asian,

CIS countries etc...

. Applying licenses like manufacturing, free sale certificate, GMP

certificate.

SKILLS:

. Database : Oracle Argus Safety Database 6.0 (for

Pharmacovigilance)

Pharma ready, Docubridge and

CTRessaiance (for electronic

Submissions to USFDA)

. Office Tools : MS Word, Excel, Power Point.

. Operating System : Windows98, xp,windows7

EDUCATION QUALIFICATION:

Bachelor of pharmacy from Vels college of Pharmacy of Dr. MGR University,

Chennai (1995-1999).

TRAININGS & CERTIFICATIONS:

. Undergoing Certified Training Programme in Pharmacovigilance with Oracle

Argus Safety Database training module from Gratisol Labs.

. Undergone certificate training Programme on EU and US Regulations

(Covering EU Directive 2004 27 EC of the European parliament, EMEA

policies on EU directive 2004 27 EC, GMP Certificates, CEP Certificates

of suitability (EDQM), FDA Risk based approach)

PERSONAL DETAILS

Date of Birth : 20 August 1978

Husband's name : MBS Shankar Rao

Permanent Address : Vista Dameon C05/06/06, Block-21, Rain Tree

Park, KPHB Colony, Kukatpally, Hyderabad - 72, Andhra

Pradesh, India.

Sex : Female

Nationality : Indian

Languages Known : Telugu, English, Tamil and Hindi

DECLARATION:

I do hereby declare that the particulars of information and facts stated

herein above are true, correct and complete to the best of my knowledge

and belief.

- M. Lakshmi

Sowjanya

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