▷ (Immediate Start) Drug Safety Specialist- Safety Surveillance, Signal Management and Risk Manageme

3 days ago

Bengaluru, India Biocon Biologics Full time
We are seeking a drug safety specialist in Safety Surveillance and Risk Management who is responsible for safety signal management activities, risk management plans & overseeing aggregate report scheduling, preparation, and submission, responding to safety questions from internal and external stakeholders, reviewing the medical and scientific literature for safety information and supporting clinical trial PV safety activities. The right candidate will have leadership skills, be an excellent communicator with an ability to have oversight over CRO activities, monitor safety compliance and can successfully lead and influence external and internal stakeholders. DSS also serves as a subject matter expert for drug safety, cross-functional teams and vendors on relevant global safety regulations and guidelines and data output and analyses.

Responsibilities:

- 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

Additional Responsibilities:

- Device safety trend analysis- PV Safety writing activities to support biosimilar publications- Training Management Support- PV trainings for BBL employees- PV Vendor Oversight

Other Drug Safety Specialist responsibilities include:

- 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.

Qualifications

- Master's degree, equivalent or higher qualification within Life sciences/Pharmacy/Healthcare Degree in alternative Medicine / BDS / PhD with at least five years of pharmacovigilance experience (minimum 3 years of experience in the aggregate reports, safety signal, RMP etc.) in the pharmaceutical industry, clinical care setting, or Academia.- Knowledge of the biopharmaceutical industry, with an understanding of applicable guidelines, regulations and best practices for conduct of pharmacovigilance activities.- Good written and verbal communication skills as well as strong interpersonal skills, with impeccable attention to detail- Must have knowledge of common data processing software like MS office tools (Excel, Power Point, Microsoft Word etc)

Job Location:

Bangalore, India.

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