Clinical Safety Physician

TCS is hiring for Clinical Safety Physician

Role: Clinical Safety Physician 

Qualification: MBBS and/or MD 

Required Technical Skill Set

• Literature: o Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports).

 o Provide MAH comments for selected literature o Review of Literature Strategy o Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER (e. g 5.2.4, 6.2, 9.2, 15 & 16).

o Providing MAH comments to literature presented under literature sections. o Authoring of RMP updates & implementation plans. o Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses.

o 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. o Review of outputs triaged by the safety scientist for scientific accuracy taking into consideration all of the above criteria

• Aggregate Reports:

o Asses the new information received on important safety concerns for the medicinal product.

o 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 sys tems 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

• Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy 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. o Lead internal escalation meetings to ensure quick response to any quality concerns or customer escalations, ensuring appropriate representatives from stakeholders and operational management are involved as appropriate.

o Lead meetings with internal and external stakeholders General Knowledge and Skills o Knowledge of relevant regulatory & scientific guidelines o 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.