Bridgewest India (Bridgewest Perth Pharma) is looking for Safety scientist position.
Job Title: Safety Scientist
Job Overview: The Safety Scientist performs global pharmacovigilance activities including the surveillance of adverse events from all sources, clinical trials, post-marketing and literature, and the preparation of safety annual reports. Assists with management of safety database function, international PV agreements and safety data exchange processes, and other internal and external groups as described in applicable SOPs.
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
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.
Review of local/global literature reports to determine regional reportability.
Responsible for literature search for ICSR`s and safety information on PubMed and EMBASE databases.
Assistance in drafting and maintenance of PSMF.
Assist in QPPV office, LPPV and LLM.
Eudravigilance profile maintenance
Skills: ICSR
Experience: 2 to 4 years
Location: Hyderabad
Mode of work: Hybrid
Interested candidates kindly share the updated resume to cshaik@bridgewestgroup.com