Sr. Dsa/Dsa

1-6 years

Not Disclosed

Mysore

12 Feb. 8, 2024

Job Description

Job Type: Full Time Education: Any Graduate Skills: Communication Skills, Interpersonal Skill, Technical Skill

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Analyzes, reviews, and interprets safety data, both non-clinical and clinical, literature and any other relevant sources
Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines
Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies
Responsible for identifying duplicate/invalid ICSRs
Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-serious reports
Perform data entry for all subject information into EDC databases as required
Perform peer review, quality review of cases as and when required
Accountable for sending queries for clarity associated with incoming information if required
Ensure accurate and consistent coding of all the events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD).
Ensure that case narrative comprises correct and appropriate safety information
Ensure that all the cases being processed with quality and submitted in a timely manner without any delays according to the service level agreement.
Contributes to safety and pharmacovigilance training programs.
Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community.
Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
Training and mentoring of Pharmacovigilance Associates
Assures and exerts activities leading to effective cooperation with clients in literature monitoring.
Ensures that the Literature Screening responsibilities and activities are managed in a cost-efficient manner of the highest quality and in compliance with global regulations and company policies and in accordance with any Pharmacovigilance (PV) agreement.
To assist with the development of literature search strategy using various methods
Perform literature screening activities to identify potential ICSRs and other relevant safety related information pertaining to client products.
To maintain a record and track all literature abstracts screened and full literature article reviewed/ordered.
To forward any ICSRs to PV Associates for data entry into the global drug safety database
Perform peer review QC of abstracts.
Accessing EV on daily basis and downloading MLM search and MLM ICSR results (excel spreadsheets)
Tracking all the MLM search results, MLM ICSRs list downloads and exported ICSR.
Assisting in departmental regulatory inspection preparedness for the company PV system in the EU and actively participating in PV inspections or audits

EDUCATION AND EXPERIENCE REQUIRED:

Minimum 1 years of relevant experience in Drug Safety for DSA, minimum 3 years for Sr. DSA role and minimum 1 year of relevant experience in Literature Screening or Literature case processing
Degree in Life Science/Pharma or Equivalent

PREFERRED SKILLS:

Awareness of Drug Safety database, Scientific coding browser: MedDRA, WHO etc
In depth Knowledge and understanding of Drug Safety/Pharmacovigilance regulations with respect to pharmaceutical drugs and other related products
Strong organizational, documentation, and interpersonal skills essential to interact with clients, management, peers and cross functional teams effectively.
Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.
Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment).
Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders.
Excellent verbal, written and presentation skills.
Innovative, collaborative, initiative-taker.

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Sr. Dsa/Dsa

Job Description

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