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Safety Clinical Research

Location:
Bhubaneswar, Odisha, India
Posted:
November 15, 2020

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Resume:

RESUME

Name: RAKESH KUMAR NAYAK

Contact No.: 797-***-****, 943-***-****.

E-mail: adhuqe@r.postjobfree.com

CAREER OBJECTIVE

To work for your novel organization by utilizing my knowledge and skill for the growth and development of the organization.

EMPLOYMENT HISTORY:

From 07March2019 to till date (20 Months experience in Pharma/Clinical research) Worked on CIOMS I, F, E2B, Line listing, unstructured and MLM cases (#Literature cases).

Position: Drug safety associate

Name of the company: Bioclinica, Mysore, Karnataka, India

ACADEMIC CAREER

Qualification

NAME OF THE INSTITUTE & BOARD/ UNIVERSITY

LOCATION

M. Pharm

School of Pharmaceutical Sciences (SPS),

Siksha O Anusandhan (Deemed to be University)

Bhubaneswar

B. Pharm

BIJU PATTNAIK UNIVERSITY OF TECHNOLOGY

Bhubaneswar

OTHER QUALIFICATION

DATE

LICENSE

GOVERNING BODY/LOCATION

Apr-2019

Registered pharmacist

Bhubaneswar, Odisha

As Case Intake Member:

Responsible for case intake, duplicate check and registration, Maintain log of source documents and other communications, Duplicate case search in Pfizer Global Safety Database (ARGUS). If the case is not found in the database, a new case or follow up case to be created with below information entered: Pfizer receipt date, Safety Receipt Date, The country of incidence, Select the correct literature report type, The name of all Pfizer suspect products, The verbatim description the reporter used to describe the AE, Outcome of events, the date and time of onset of the AE, the reporter name and reporter information, the patient’s first name, last name or initials. Patient identification number, age at onset, data of birth and gender as available. The literature reference (i.e. journal and article title and author).

As Data entry:

Responsible for data entry of Individual case safety reports into the safety database, Review and evaluate AE case information to determine required action based on and following internal policies and procedures, Process all incoming cases in order to meet timelines, Full data entry including medical coding and safety narrative as required, Enter and code, as applicable, case data, including but not limited to event, seriousness, reported causality (when appropriate), medical history, and laboratory data as provided by the reporter. Code products specified as suspect or concomitant by the reporter. Provide the narrative as required, Review Adverse Event (AE) report data for completeness and verify certain fields to determine as critical (including but not limited to reportability) as well as conformity to E2B standards. Initiate follow-up activities to obtain additional information and clarification as appropriate. Forward cases for case review or invalid workflow in the global safety database. Worked on CIOMS I, F, E2B, Line listing and unstructured sources.

Secondary responsibilities: Maintain quality service and departmental standards by: Reading, understanding, and adhering to organizational standard operating procedures (SOPs), assisting in establishing and enforcing departmental standards.

Contribute to team effort by: Working with internal staff to resolve issues, Exploring new opportunities to add value to organization and departmental processes, helping others to achieve results, performing other duties as assigned.

Maintain technical and industry knowledge by: Attending and participating in applicable company-sponsored training.

Additional Skills: Strong motivational skills and abilities, promoting a team-based approach, Strong interpersonal and communication skills, both verbal and written in English, Strong organizational and leadership skills, Goal-oriented, Ability to maintain professional and positive attitude.

PERSONAL DETAILS:

Father’s Name : Mr. GANGADHAR NAYAK

Date of Birth : 28/09/1992

Nationality : Indian

Gender : Male

Conversant in : English, Hindi, Punjabi and Odia

Permanent Address : At-LIG 6/48 BDA Colony, P.O- Housing Board Colony

Dist.-Khordha, City- Bhubaneswar, PIN- 751016, State-Odisha.

Present Address : 44, 44/1 Jaylakshmipuram, City- Mysore

PIN- 570012, State –Karnataka.

ACKNOWLEDGEMENT:

I do hereby declare that all the information furnished above are true to the best of my knowledge & if anything found incorrect/false, my resume is liable to be rejected at any point of time.

Place :

Date : (Signature)



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