Andhra Pradesh Research operations occupations Jobs – 4 Open Jobs Today

PV COORDINATOR - FSP
Thermo Fisher Scientific —Andhra Pradesh
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Access
Clinical Research Specialist
Katalyst Healthcares & Life Sciences —Guntur, Andhra Pradesh
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Nursing
Quick apply
Scientific Research Head, Drug Discovery
Katalyst Healthcares & Life Sciences —Guntur, Andhra Pradesh
- Full-time
- Hybrid work
- Doctoral degree
- Research
- AI
Quick apply

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PV COORDINATOR - FSP

Thermo Fisher Scientific -
Andhra Pradesh

Apply Now

Job details

Full-time

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Access
Microsoft Office
Science
Data entry
Computer skills
Communication skills
FDA regulations

Full job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a PV Coordinator – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to provide contracted project coordination and safety support on global and domestic programs. As a PV Coordinator, you'll focus on serious and non-serious adverse events, protocol inquiries, physician assessment of diagnostics, Data and Safety Monitoring Boards, and Endpoint Adjudication Committees. In collaboration with Safety Specialists and Medical Monitors, you will liaise and establish effective relationships with internal functional team members to implement projects, prepare contractual documents, coordinate and facilitate meetings, and accurately manage all incoming safety documentation.

What You’ll Do:

Coordinates the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data; tracks all necessary data and generates reports for the client, project team and/or external vendors.
Represents the organization's DSMB/EAC Coordination Team at global and domestic committee meetings (both via teleconference and face-to-face) alongside the client, board members, third party vendors and the project team, coordinating all logistical aspects and assisting with facilitation.
Interfaces with various internal and external parties to implement projects, prepares Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations; reviewing all contractual documents for accuracy and coordinating internal and external approvals.
Compiles adjudication dossiers and creates/submits follow-up to investigative sites.
Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams.
Manages project specific training and the set-up, maintenance and archival of program files; ensuring PV remains audit ready.
Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to the organization's Data Privacy.
Performs data entry into internal/external databses, tracking systems and the organization's budget management system; performs system reconciliations to identify issues which may negatively impact project timelines.
Oversees expenses and manages translations; ensuring budget parameters are not exceeded.
Answers incoming hotline calls, coordinates department functions and performs other duties as assigned.
Supports any specific activities performed by the local office, which cannot be performed from elsewhere.
Provides training to junior staff.

Education and Experience Requirements:

- Graduation in any Life Science degree is preferred
- 1+ Years of experience in Pharmacovigilance Case processing is required
Having experience in Argus database is Manade

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

Strong problem-solving skills
Ability to work independently with minimal supervision, demonstrating initiative
Ability to build strong relationships
Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members and other internal staff
Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
Excellent computer skills to include MS Office (Word, Excel, PowerPoint, Access)
Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlines
Strong attention to detail and accuracy with orientation toward careful and meticulous work
Ability to maintain a positive and professional demeanor in challenging circumstances
Flexibility to reprioritize workload to meet changing project timelines
Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and the organization's/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout

Working Conditions and Environment:

Work is performed in an office environment with exposure to electrical office equipment
Potential drives to site locations and/or travel required on rare occasion
Majority of work on a computer-based
Long varied hours required on occasion.

Apply Now

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research operations occupations jobs in andhra pradesh

PV COORDINATOR - FSP

Clinical Research Specialist

Scientific Research Head, Drug Discovery

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