Drug Safety Physician
2 weeks ago
We are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk management activities and drive proactive implementation of risk management initiatives to meet global regulatory requirements. The right candidate will have leadership skills, be an excellent communicator with an ability to have oversight over CRO activities and can successfully lead and influence external and internal stakeholders. DSP also serves as a subject matter expert for product-specific safety information.
Responsibilities:
- Contributes to the development & maintenance of product safety profile.
- Involved in all safety surveillance activities, which may include monitoring of adverse event and all other safety information to manage the safety profile of the company products
- Collaborates with, medical monitors and other functional groups in identification, analysis, and reporting of possible safety-related trends or concerns.
- Responsible for the evaluation of safety data from pre-clinical studies, clinical studies, literature and other sources to establish safety profile of company products to manage risk to the patients
- Provides medical input into the identification and utilization of appropriate sources of information and database searches to retrieve relevant data for signal evaluation
- Discuss results of data evaluation with pharmacovigilance safety review team, drug safety committee and/or other key stakeholders
- Provides inputs to literature search strategy and review to effectively determine appropriate and relevant literature for the purposes of safety analysis.
- Responsible for the review of the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) providing expertise to the medical content of the safety specification, risk management plan, risk minimisation measures including the locally implemented risk minimisation measures and drives the implementation of risk minimisation activities in accordance with global regulatory requirements.
- Provides medical input in ensuring that risk minimisation strategies are implemented appropriately in relevant documents such as product reference safety information
- Collaborates with external provider representatives in the preparation and review of aggregate reports having thorough oversight over the critical aspects like summary of safety concerns, benefit risk evaluation, conclusion etc
- Have thorough medical oversight over the external vendors on the medical review of ICSRs
- Provides medical inputs to deliver accurate safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data
- Provides medical inputs in responding to safety questions from regulatory authorities and partners in collaboration with service providers and cross-functional teams
- Review and provides medical inputs to the safety sections of CCDS, local label updates, health hazard analysis, QA trend analysis, device hazard lists, CER etc
- Understands the role of QPPV and contributes to the maintenance of the pharmacovigilance system and process
- Provides inputs to various pharmacovigilance documents like PSMF, SDEA
- Provides input and review for key regulatory or clinical documents (i.e. SMP, protocol, IB, SAE/SUSAR, safety sections of DSUR, ASR, CSR, integrated summaries of safety etc.) related to pharmacovigilance
- 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
- Participates and supports pharmacovigilance audit/inspection preparation and CAPA management
- Participates in internal pharmacovigilance committee meetings as well as joint safety meetings with partners.
- Provides inputs in the preparation/revision of SOPs, working guidance and ensuring pharmacovigilance compliance.
- Meets pharmacovigilance commitments to regulatory authorities with respect to marketing authorization.
- Follows good pharmacovigilance practices (ICH, Eudravigilance, local regulations etc).
- Trains and mentors the team members.
Other Drug Safety Physician responsibilities include:
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
- Includes knowledge of case processing, expedited reporting and safety database concepts
- Proactively raises concerns/issues to senior management in a timely and appropriate manner ensures quality and integrity of the issue/event being escalated
- Demonstrates leadership and interacts collaboratively and effectively in team environment (including safety, clinical development, medical affairs,regulatory, commercial, devices) as well as with external stakeholders
- 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
- MBBS/PhD/MD with 7+ years of pharmacovigilance experience in the pharmaceutical industry, clinical care setting, or Academia
- Knowledge of the biopharmaceutical industry, drugs and indications with an understanding of applicable guidelines, regulations and best practices for conduct of pharmacovigilance activities.
- High degree of professionalism, maturity, business understanding and passion.
- Strong written and verbal communication skills as well as strong interpersonal skills, with impeccable attention to detail
- Ability to collaborate effectively with internal and external stakeholders at all levels and influence decision-making.
- 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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Biocon Biologics | Drug Safety Physician | india
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