Skill: Clinical Study Physician

Location: Mumbai/Bangalore/Noida

Shift: General Shift

Band: BPO 3/4/5/6

Salary Range: 9 - 20 LPA

Educational Qualification: MBBS and/ or MD





**The candidate should be in either Mumbai/Bangalore/Noida

**International BPO experience is required**



Required Technical Skill Set:

Literature: 

•    Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion n 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 (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. 

•    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 j



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 (timelin



General Knowledge and Skills 

•    Knowledge of relevant regulatory & scientific guidelines 

•    Ability to present / communicate effectively with stakeholders on safety topics. 

• 



Responsibility of / Expectations from the Role:

•    Provide mentorship, oversight and training of less experienced colleagues. 

•    Have a good understanding of all in scope processes. 

•    Contribute to all signal management activities with medical expertise, i.e. contribute to dete



Expectation of working in A Matrix Model

•    Take proactive ownership of delegated molecule safety activities, contributing to ensuring patient safety and the molecule’s safety strategy, i.e. proactive suggestions for SRP, DSR strategy, addressing SRR topics.  

•    Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action) /deliverables  

•    Consistently delivering quality the first time across p



**PAN and DOB are required to create an employee profile in the database.**