Safety Reporting Admin

7 months ago

Andhra Pradesh, India Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

**Discover Impactful Work**:
Provides administrative safety support to the Pharmacovigilance department. Specifically in relation to submissions, tracking and subsequent filing and archiving or expedited and periodic safety reports. This includes other general administration tasks such as filing, photocopying, typing and performing reconciliation tasks. Involved in projects relating to safety reporting. May mentor or train new central safety reporting admin staff.

**A day in the Life**:

- Responsible for the submission of safety reports to applicable parties, including subsequent scanning, indexing and filing (both electronic and paper), safety tracker completion and quality check, and archiving in accordance with SOP’s and WPD’s. Resolves simple problems with submission packs within mínimal input from manager or other administrators.
- Responsible for extracting and collating reporting information via the Clinical Trial Management System, maintain and update contact lists on PPD systems as required by Safety Specialist or Safety Reporting Specialists.
- Supports department and Pharmacovigilance initiatives as relevant.
- Responsible for training Pharmacovigilance department staff on the safety reporting process and various PPD systems associated with safety reporting.
- Assists when required, to provide filing support for multiple projects, including barcoding of safety reports, filing of safety reports, identification and reporting of any problems and inaccuracies to management, as well as responsibility for the file room in terms of cleanliness and organization.
- Assists with file reviews for completed safety reports, maintains audit notification and file return notification forms and provides assistance with on-site audits if required or requested by PPD or client.
- Responsible for the coordination of study files and inventories to client, including distribution via external postal services as needed.

**Keys to Success**:
**Education**:

- Bachelor's degree in life science/healthcare-related courses (nursing, pharmacy, biology, med tech, etc)
- Previous healthcare administrative experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 3 years).

**Knowledge, Skills, Abilities**:

- Ability to work effectively in a team to attain a shared goal and support assigned lead and line manager on tasks
- Proficiency in Microsoft Office Programs (Word, Excel, PowerPoint, Access) and solid knowledge of procedural documents
- Excellent written and verbal communication skills, including telephone conversations as well as face to face interactions with all levels of the organization
- Excellent organization and time management skills, including those of paperwork and files, with proven ability to handle multiple tasks at once and deal effectively with stress
- Strong attention to detail and accurate with orientation towards careful and meticulous work
- Strong problem solving skills

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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