Drug Safety Specialist

Job Description

• Supports the signal management process (i.e set up process for periodic signal detection for company products, signal tracking, review meetings, signal detection overview reports, eRMR reports etc) for the assigned product (s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Data from multiple sources are evaluated and authors the signal evaluation report and manages literature review for safety information.

• Prepares and maintains the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) including the risk minimization measures and is responsible for the monitoring of the effectiveness of risk minimization measures.

• Supports the process for responding to safety questions from regulatory authorities and partners in collaboration with service providers and cross-functional teams

• Collaborates with aggregate report vendors having thorough oversight over scheduling, tracking, compliance and quality.

• Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, signal management, risk management plan preparation and responding to ad-hoc safety questions

• Supports the review and provides inputs to the safety sections of CCDS, local labels, health hazard analysis, QA trend analysis, device hazard lists etc

• Follows good pharmacovigilance practices (ICH, Eudravigilance, local regulations etc).

• Participates and supports pharmacovigilance audit/inspection preparation and CAPA management.

• Prepares SOPs, working guidance and ensuring pharmacovigilance compliance.

• Follows document management as per good documentation practices and SOPs

• Oversees and mentors Drug Safety Specialist

• Ensures compliance, reconciliation, and review of safety data exchange agreement between partners.

• Meets pharmacovigilance commitments to regulatory authorities with respect to marketing authorization.

• Collaborates well with drug safety physician and cross-functional teams (medical leads, clinical operations) for assigned clinical studies including SMP preparation/review, protocol review, IB review, SAE/SUSAR review, review of safety sections of DSUR, ASR, CSR etc

• Understands, interprets, analyse and clearly presents scientific and medical data in verbal and written format.

• Includes knowledge of case processing, expedited reporting and safety database concepts

• Demonstrates leadership and interacts collaboratively and effectively in team environment (including safety, clinical development, medical affairs,regulatory, commercial, devices) as well as with external colleagues

• Must be an excellent communicator and have strong negotiation skills with an ability to have oversight over CRO activities

• Strong organisational skills, including capability to prioritise independently with minimal supervision.