Safety Reporting Coord

4 weeks ago

Bengaluru, India Thermo Fisher Scientific Full time

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

Safety Reporting Administrator’s provide administrative support to the Pharmacovigilance department, specifically in relation to submissions, tracking and subsequent filing and archiving of expedited and periodic safety reports.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:
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.

Essential Functions:

- 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.

Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Technical positions may require a certificate.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

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:

- 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 organisation 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

Working Environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. (Recruiter will provide more details.)

PPD

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