Drug Safety Associate Resume PA - Hire IT People

SUMMARY:

To Work on a challenging job profile which provides you an opportunity to enhance my technical skills and knowledge this could provide me an insight into new aspects so that it would be helpful for my career.

MY STRENGTHS:

Work with positive attitude to contribute the healthy functioning of the organization.
Good understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements.
Good understanding of computer technology, and management of relational database systems, including extraction of data.
I am empathetic and self motivated.
Good judgment, decision making and problem solving skills
I have a good level of emotional intelligence to get along with different types of people and colleagues and I can keep myself cool in hard time.
Adaptability to change environment.

SOFT WARE SKILLS:

Databases: SQL Server,oracle, Sceptre, Argus

Methodologies: Agile, SDLC, SCRUM

Reporting Tools: SSRS, SSAS, Tableau

MSBI Office Tools: MS Word, Excel, Access, Outlook, and Power Point Operating Systems

PROFESSIONAL EXPERIENCE:

Confidential, PA

Drug Safety Associate

Responsibilities:

Responsible for participating in the collection, safety review, processing and reporting of adverse events data incompliance with applicable Confidential and global regulations and company Standard Operating Procedures (SOPs) and guidelines.
Cross - trains in Product Quality Complaint Handling Procedures to ensure a fully cross-functional environment. Assists with determination of root causes of non-conformances.
Manages Product Quality Complaint records as assigned requiring either initial or follow-up with Suppliers, review of investigation results, documentation in PQC Management System, investigation and/or closure.
Provide quality review and coordination with Product Quality when an adverse event is associated with a product complaint, including review of the PQC Investigation Reports.
Participates in interdepartmental, team, and other committee meetings as necessary.
Promptly and accurately interpret and enter serious and non-serious adverse events into the global database for distribution.
Creating comprehensive narratives procured from relevant, related information from various source documents.
Requesting all pertinent follow up information for the completion of case reports within specific timelines as prescribed by global regulations and SOPs.
Create comprehensive narratives procured from relevant, related information from various source documents.
Comprehensive understanding of labeling (Company Core data sheet and labeling reviews).
Review an accurate coding of incoming serious and non-serious adverse events (AEs), medical history, laboratory data and drugs using Med DRA terminology and Confidential -Drug dictionaries.
Accurately identify, classify, interpret and enter serious and non-serious adverse events into global database for distribution depending on listedness and labelledness of the drug.
Interact with company representatives, project teams, clinical sites, CROs, and other members of risk assessment teams.
Maintain current knowledge of all applicable Confidential /EU/ICH guidelines and regulations relating to safety and Pharmacovigilance reporting.
Ensure all Sponsor, and regulatory timeframes are met for the processing and reporting of safety information.
Data collection and entry of adverse events (AEs)/Serious Adverse events (SAEs) received from clinical trials and/or post marketing sources in a timely fashion to ensure compliance with local and global regulatory reporting.
Provide retrieval and reporting of data from the Sceptra’s database. Ad hoc data extraction and reporting as requested by internal and external customers.

Confidential

Drug Safety Associate

Responsibilities:

Assisting doctors in various medical and surgical diagnostics procedures.
Maintain records in the ward.
Maintains general cleanliness of the ward and sanitary annexure.
Takeover duty nurse of the previous new and serious patients instruments, supplies drug etc. and handover the same accordingly.
Maintains all the recording pertaining to ward.
Write day and night orders and maintain statistics.

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Drug Safety Associate Resume

PA

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