Location
India | India
Job description
- 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
- Perform peer review, quality review of all EDC data entered as 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
EDUCATION AND EXPERIENCE REQUIRED:
- Minimum 1+ year of experience in drug safety or clinical research domain
- Degree in Life Science/Pharma or Equivalents
PREFERRED SKILLS:
- 1+ year of 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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