Location
Mysore | India
Job description
- 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.
- Track all the reports for which full literature article ordered
- 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
- Keeping the EMA MLM Literature Screening Tracker up to date with the latest information received from the EMA.
- 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 Literature Screening or Literature case processing
- Degree in Life Science/Pharma or Equivalent
PREFERRED SKILLS:
- 2 + year of relevant experience in drug safety, clinical research domain
- Awareness of 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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