Clinical Safety Physician(PSL)

Job description

TCS is hiring for Clinical Safety Physician Role

Clinical Safety Physician Qualification: MBBS and/or MD Required Technical Skill Set

Literature

• Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports).
• Provide MAH comments for selected literature
• Review of Literature Strategy
• Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER (e. g 5.2.4, 6.2, 9.2, 15 & 16).
• Providing MAH comments to literature presented under literature sections.
• Authoring of RMP updates & implementation plans.
• Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses.
• Thesaurus used for indexing medical scientific literature, relevant for literature search strategy tailoring (both ad-hoc and systematic). Review and interpretation of current expert therapeutic guidelines for the purpose of various safety analyses.
• Review of outputs triaged by the safety scientist for scientific accuracy taking into consideration all of the above criteria

Aggregate Reports

• Asses the new information received on important safety concerns for the medicinal product.
• Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy
• Signal Management
• Review of various types of listings for Signal Detection
• Understanding of signal journey and knowledge of signal management systems and process requirements.
• Perform Signal validation with a summary.
• DSR - Complete authoring, Single case analysis & MAH comments, Drafting Overall Conclusion and Review
• Tailoring strategy and methodology for signal assessment
• Overall assessment of the signal based on the presented data and respective recommendations for action

Project Management

• Manage customer interface, communication and deliverables for assigned molecules/documents/deliverables.
• Tactical, day-to-day customer-facing leadership at project/program level. Responsibilities include project strategy, planning (timelines, deliverables), scope management and project financial management.
• Lead internal escalation meetings to ensure quick response to any quality concerns or customer escalations, ensuring appropriate representatives from sta keholders and operational management are involved as appropriate.
• Lead meetings with internal and external stakeholders

General Knowledge and Skills

• Knowledge of relevant regulatory & scientific guidelines
• Ability to present / communicate effectively with stakeholders on safety topics.
• Ability to speak up effectively and ensure that questions and unclarities are addressed or negotiate/adapt the plan for the work.
• Knowledge across responsibilities of relevant stakeholders and process.
• Ability to work in a team with different stakeholders.
• Prioritize and delegates tasks based on the importance of the deliverables and awareness of overall timelines.
• Providing training with respect to medical aspects of drug safety to various stakeholders. </p

Qualifications

MBBS, MD