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Tata Consultancy Services · Mumbai

# Clinical Safety Physician(PSL)

Mumbai Healthcare & Clinical 

Last seen on Tata Consultancy Services’s official careers site on August 1, 2026; it may have closed since.
[Apply on Tata Consultancy Services’s careers site →](https://ibegin.tcsapps.com/candidate/next/en-IN/jobs/422356J)

[OpenNash Jobs](https://jobs.opennash.com/) / [Tata Consultancy Services](https://jobs.opennash.com/companies/tata-consultancy-services/) / 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

## At a glance
- Posted by the employer: Not stated
- First seen by OpenNash: Aug 1, 2026
- Last checked: Aug 1, 2026
- Listed for: Under a day
- Location: Mumbai[Apply on Tata Consultancy Services’s careers site →](https://ibegin.tcsapps.com/candidate/next/en-IN/jobs/422356J)

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