Clinical Sturdy Scientist
Job Description
Key Skills
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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.**
Role
Any Other
Timings
Rotational Shifts (Permanent)
Industry
BPO
Work Mode
Work from office
Functional Area
Any Other
Note: Myglit doesn't charge any money from candidates. If you have been asked to pay money to get this job then report to us immediately at support@myglit.com.
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