Drug Safety Specialist

Biocon Biologics; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Biocon Biologics in Bengaluru, India is seeking a Drug Safety Specialist to support pharmacovigilance activities, signal management and risk minimization efforts for assigned products. The role involves cross-functional collaboration with medical, clinical development and regulatory teams to review safety data and respond to questions from authorities.

The candidate will help prepare RMP/REMS, participate in audits, and ensure compliance with SOPs and good documentation practices while mentoring

Responsibilities

• Supports signal management process for periodic signal detection and signal evaluation.
• Prepares and maintains Risk Management Plans (RMP/REMS) including risk minimization measures.
• Responds to safety questions from regulators in collaboration with cross-functional teams.
• Contributes to aggregate reporting, signal management and risk management improvements.
• Reviews safety sections of CCDS, local labels, QA trend analyses and device hazard lists.

Job description

Drug Safety Specialist- Safety Surveillance and Risk Management

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

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.