Skill: Clinical Safety Scientist

Location: Mumbai/Bangalore/Noida

Shift: General Shift

Band: BPO BPO 4/5

Salary Range: 11 - 16 LPA

Educational Qualification: Any Life science graduate exclude B.Pharm

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

**Graduation is compulsory**

**International BPO experience is required**

Required Technical Skill Set:

Literature: 

•    Literature review to assess ICSR, new safety si

 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 th

 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

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 financi

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. 

•    Attending and presenting at medical scientific conferences or publishing [optional, outside of scope of responsibilities]

Responsibility of / Expectations from the Role:

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

•    Have a good understanding of all in scope processes. 

 

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.  

 

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