Thermo Fisher Scientific is hiring B. Pharma/ M. Pharma as a Safety Specialist / Sr Safety Specialist – Apply Now

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Unlock your potential in pharmaceutical safety with Thermo Fisher Scientific! Join our dynamic team as we seek passionate B. Pharma/M. Pharma professionals to fill the role of Safety Specialist/Sr Safety Specialist in Hyderabad. Dive into a career where your expertise in pharmacovigilance meets cutting-edge innovation, ensuring the safety of life-changing medications. Discover endless opportunities for growth and impact with us.

Job Description

You’ll Coordinate And Perform PV Activities Such As Data Entry, Coding, Adverse Event Assessment, Case Review, Follow-Up, Tracking Of Reports, And Regulatory Reporting Activities. Effective Collaboration With Project Team Members, Client Contacts, Investigators, Adverse Event Reporters, And Third-Party Vendors Is Essential. You May Also Assist In Preparing Departmental And Project-Specific Procedures, Attend Audits, And Mentor Less Experienced Staff.

Essential Functions:

1. Perform Day-To-Day PV Activities, Including On-Call Duties For Specific Projects To Ensure 24-Hour Coverage For Case Intake.
2. Stay Updated On Current Regulations, Practices, Procedures, And Proposals By Reviewing Regulatory/Pharmacovigilance Publications And Information Sources.
3. Maintain Medical Understanding Of Applicable Therapeutic Areas And Disease States.
4. Review Cases Entered For Quality, Consistency, And Accuracy, Including Peer Report Review.
5. Prepare And Maintain Regulatory Safety Reports.
6. Assist With Routine Project Implementation And Coordination, Including Presentations At Client/Investigator Meetings And Review Of Metrics And Budget Considerations.

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Education And Experience:

1. Bachelor’s Degree Or Equivalent With Relevant Formal Academic/Vocational Qualification.
2. Previous Experience Equivalent To 2+ Years Providing The Knowledge, Skills, And Abilities Required For The Role. In Some Cases, A Combination Of Appropriate Education, Training, And/Or 3. 3. Directly Related Experience Will Be Considered Sufficient.

Knowledge, Skills, And Abilities:

1. General Understanding Of Pathophysiology And Disease Processes.
2. Detailed Knowledge Of Relevant Therapeutic Areas For Processing Adverse Events.
3. Strong Critical Thinking And Problem-Solving Skills.
4. Excellent Oral And Written Communication Skills, Including Paraphrasing.
5. Proficiency In English And Ability To Translate Information Into Local Languages Where Required.
6. Computer Literacy, Including Experience With Microsoft Office Packages (Outlook, Word, Excel), And Ability To Work Within Multiple Databases.
7. Understanding Of The Importance Of Procedural Documents And Regulations Compliance.
8. Ability To Manage And Prioritize Tasks, Meet Strict Deadlines With Limited Supervision, And Maintain Attention To Detail.
9. Professional Demeanor And Ability To Work Effectively Within A Team To Achieve Shared Goals.

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