Project Manager Registered Nurse

M E E NA TANEJA t *****@*****.*** 847-***-****

OBJECTIVE: I am a well qualified and highly motivated healthcare professional with extensive experience in

Pharmacovigilance, Drug Safety, Quality Assurance and Project Management. I am seeking a challenging position

that supports patient safety for developmental and marketed compounds.

EMPLOYMENT

Takeda Pharmaceuticals North America, Inc. 2007-Present

Pharmacovigilance Project Manager (2011- Present)

• Lead global teams to create Periodic Benefit Risk Evaluation Reports (PBRER)

• Assist with signal detection activities for assigned products

• Review Safety Data Exchange Agreements

• Respond to requests from Regulatory Agencies

• Train global teams on aggregate reports

• Assist with compiling Development Safety Update Reports (DSUR)

• Collaborate with IT to develop reports to increase efficiencies

• Devise processes and provide training for reconciliation and global distribution of adverse event reports

Pharmacovigilance Specialist II (2008- 2011)

• Compile IND Annual reports, periodic reports and Periodic Safety Update Reports (PSUR)

• Coordinate submission of reports with Regulatory Affairs

• Provide training for compiling periodic reports and PSURs

• Review expedited submissions and periodic reports

• Coordinate activities for audits

• Identify process improvements and draft applicable documents

• Assist with writing and reviewing SOPs

• Assist with database integration

• Code and label adverse events and code medications by using AUTOCODE software

Lead Pharmacovigilance Specialist (2007- 2008)

• Compile and analyze safety data for periodic reports for postmarketed products

• Support regulatory submission of marketed/co-marketed products by compiling and reviewing periodic

reports and PSURs

• Develop training manuals/templates for compiling PSURs

• Support EU marketing application

• Compile signal reports for a postmarketed product

• Assist with identifying and piloting signal detection procedures for developmental and marketed compounds

• Conduct literature searches for postmarketed products

• Conduct employee/sales training pertaining to adverse event reporting

M E E NA TANEJA t *****@*****.*** 847-***-****

TAP Pharmaceutical Products 2000-2007

Associate Project Manager, Clinical Quality Assurance (2005 – 2007)

• Research and collect information necessary to complete the audit plan

• Manage, document, and communicate the information

• Obtain standard audit documents prior to an audit

• Create audit binders for auditors

• Provide initiatives for process improvement

• Assist with the planning of GCP audits by researching and collecting information

• Assist with review of audit reports

• Utilize eClinical, Medidata, and QAAD databases

Senior Pharmacovigilance Specialist (2004 – 2005)

• Investigate and collect follow-up information for complicated safety reports

• Write coherent descriptions of collected safety data

• Conduct department training sessions

• Conduct training sessions for new employees within the Safety Surveillance group

• Conduct sales training pertaining to adverse event reporting

• Coordinate with and communicate safety data to Product Complaints, Analysis, Central Coding Unit, Risk

Management/Medical Information, and Safety Review

• Coordinate safety data with Regulatory Agencies and business partners

• Conduct queries to retrieve relevant safety information

• Compile and analyze safety data for periodic reports for TAP’s postmarketed products

• Assist with writing SOPs

• Assist with devising procedure for submitting periodic reports to the FDA via CD-ROM

• Devise process for conducting literature searches

• Conduct literature searches and order publications

• Assist with the validation of software updates

Pharmacovigilance Specialist (2002 – 2004)

• Collect, interpret, and process safety related information in a timely and accurate manner

• Assess adverse event reports to identify potential safety signals

• Write coherent descriptions of collected safety data

• Provide safety information ensuring that patient safety is protected

• Transfer safety data into the safety database in a timely and accurate manner

• Utilize multiple software applications like ARISg, Microsoft Word, Lotus Notes, and PowerPoint

• Prioritize daily activities with respect to timelines and goals

• Acquire, maintain and communicate information about TAP’s products clearly and efficiently

• Understand and apply regulatory regulations to reporting of adverse event

• Conduct literature searches for TAP’s postmarketed products and those under clinical investigation

Medical Services Specialist (2001- 2002)

• Respond to inquiries and reports by health professionals, patients, and sales representatives

• Use medical knowledge to assist clients to correct techniques that may have resulted in quality problems

• Provide assistance to the medical community and laymen with "labeled" and "off-label" information,

and product complaints

• Work with Customer Service to provide product replacement

• Inspect returned products for quality issues

M E E NA TANEJA t *****@*****.*** 847-***-****

• Draft custom letters in response to a request

• Act as a liaison with Quality Assurance for product quality problems

• Ensure accurate entry of information into the database

Clinical Investigation Specialists Project Leader (2000-2001)

• Manage Phase III and Phase IV clinical studies on site

• Recruit, screen, enroll, and schedule study participants for clinical studies

• Utilize physical assessment skills to collect and evaluate data on study participants, and monitor subjects for

adverse reactions

• Adhere to protocol, regulatory and administrative requirements for clinical studies

• Document all stages of clinical studies by maintaining current and accurate case report forms and study

document books

• Assist with investigator recruitment and selection

• Discuss new protocols with potential investigators

• Obtain IRB approval for study investigators

• Provide site support and communication by serving as a resource person for pharmaceutical companies,

study investigators, site personnel, and study participants

• Act as a liaison between pharmaceutical companies and investigators

• Ensure that study sites adhere to Sponsor, FDA, and protocol guidelines

University of Maryland. College Park (1987-1993)

Program Analyst (1991-1993)

• Manage department operations and supervise staff, and monitor completion of work

• Interview, hire and train staff, identifying qualified candidates for multiple positions and provide necessary

direction to assist personnel in performing according to expectations

• Assist with implementation of new computer system to increase efficiency by collaborating with

programmer

• Schedule classroom space for 350 courses at the university with 35,000 students, and update university

catalogue

•Disseminate project information and provide updates to department leaders

• Collaborate with department leaders to plan use of university facilities for courses and events

Staff Assistant (1987-1991)

• Schedule classroom space for 350 courses at the university with 35,000 students and update the catalog

• Disseminate project information to university community, providing detailed updates to staff concerning

facilities scheduling and changes affecting courses

EDUCATION

A.S., Nursing, Prince Georges Community College, Largo, Maryland 1999

B.S., Business Management (cum laude), University of Maryland,

College Park, Maryland 1992

B.Ed., Education, University of Delhi, Delhi, India 1980

M.S., Botany, University of Delhi, Delhi, India 1979

B.S., Botany, University of Delhi, Delhi, India 1977

LICENSURE

M E E NA TANEJA t *****@*****.*** 847-***-****

Licensed Registered Nurse, State of Illinois 2000

Licensed Registered Nurse, State of Virginia 2000

HONORS

Dean's List, Prince Georges Community College, Largo, Maryland 1998-1999

Golden Key National Honor Society, University of Maryland, College Park, Maryland 1990

Beta Gamma Sigma Business Honor Society, University of Maryland, College Park, Maryland 1990

Senatorial Scholarship, University of Maryland. College Park, Maryland 1987 -1988

Dean's List, University of Maryland, College Park, Maryland 1987-1988

Phi Kappa Phi Honor Society, University of Maryland, College Park, Maryland 1987

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