Safety Surveillance Physician

TCS is Hiring

• Clinical Safety Physician

location

Experience Range

Preferred Educational Qualification for the role

Job Description

Literature Review

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

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 :

Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER.

Authoring of RMP updates & implementation plans.

Provides methodology (in collaboration with Roche clinical safety) for data presentation and assessment in the pertinent safety sections of the aggregate report (use outside the indication scope, use in special population, medication errors, characterization of risks etc.)

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 brief 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 recommendation for action

Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy