Responsibilities
Role in Data entry:
- Role in Data entry: Responsible for triage, review and process information on adverse events received from various sources on time by performing initial checks.
- 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
- Experience in various databases like ARGUS, ARISG, Clinevo and AB Cube. Full data entry including medical coding and safety narrative Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)
- Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
- Following up with sites regarding outstanding queries.
- Follow-up on reconciliation of discrepancies. Follow departmental AE workflow procedures. Closure and deletion of cases.
- Perform submission activities (Submission of ICSR`s to US FDA, TGA and EVCTM) Understanding and application of good documentation. Perform any other drug safety related activities as assigned
Role In Quality Review
- Process safety reports (Pre and post-marketing) according to the SOP`s and Project specific procedures.
- Responsible for the QA review of ICSRs for completeness, accuracy, medical relevance, and overall consistency of information captured in the safety database against all applicable supporting documents as per the client requirement.
- Responsible for review of various source documents like Targeted follows up checklists, Investigational summary and lab data. Responsible for review the narrative to ensure that all information has been captured in a systematic manner as per the client requirement.
- Accountable for performing clinical assessments (seriousness, causality and labelling based on various regulatory documents such as CDS, IB, BPI and USPI).
- Communicate the QA observations to the applicable stakeholders and ensure that the appropriate RCA/CAPA is obtained from the respective stakeholders for the applicable QA observations as per client requirement
Key Responsibilities
- Role in literature search Review of local/global literature reports to determine regional report ability.
- Responsible for literature search for ICSR`s and safety information on PubMed and EMBASE databases.
- Responsible for a thorough review of all the remaining abstracts for identifying ICSRs based on valid case criteria.
- Responsible for rerouting of abstracts with safety information without ICSRs to signal detection team for inclusion during aggregate reporting.
- Responsible for prioritization of book in of ICSRs from literature sources in accordance with seriousness assessment and report ability criteria of different health authorities
- Perform appropriate case follow-up activities by generating follow-up letters and follow-up questionnaire for both pre and post marketing reports. Assistance in database setup activities.
- Handling of Safety Mailbox. Assistance in drafting and maintenance of PSMF. Assist in QPPV office, LPPV and LLM. Handling of Weekly and Monthly reconciliation reports. Weekly EVWEB and DEAN search for ICSR`s.
- Preparation of KPI tracker and Compliance tracker for assigned activities.
- Maintenance of EURD list and review of monthly PRAC meeting highlights. EV HUMAN and E2B case processing.
- Eudravigilance profile maintenance Drafting of SOP`s and Data entry conventions in line with the company requirements.
- Working quickly by multi-tasking and demonstrating the ability towards good quality service by providing the need full information on product.
- Experience in writing and reviewing of SOPs Demonstrates knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, FDA, PMDA, EMA, TGA, ICH, etc.)
Experience And Professional Qualifications
- 2-6 years experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products is preferable.
- B.Pharmacy/M.Pharmacy/ Pharm D with relevant experience in the pharmaceutical/CRO industry required.
- Good working knowledge of US and EU drug safety regulations, TGA, CIOMS and ICH guidelines. Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities.
- 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 NovaCina/LumaCina and with outside stakeholders.
- Excellent verbal, written and presentation skills. Innovative, collaborative, initiative-taker
Skills: presentation skills,literature,argus safety,database,written communication,drug delivery,literature search,safety regulations knowledge,verbal communication,safety narrative writing,relationship building,data entry,database management,clinical assessments,quality review,medical coding
