Safety Writer
Lifelancer
Date: 2 hours ago
City: Remote, Remote
Contract type: Full time
Remote
Job Description
Summarized Purpose:
Responsible for the planning, coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Activities include but are not limited to delivery of low complexity safety writing deliverables through achievement of the following tasks: project management, data review, authoring, and quality review. May also support authoring of medium complexity deliverables. Effectively collaborates with various parties, including but not limited to: PVG project team members, wider PPD/Evidera project team members, client contacts and third party vendors.
Essential Functions
writing deliverables (e.g. line listing reports; Periodic Adverse [Drug] Experience Reports] (PA[D]ERs)).
(PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), development Risk Management Plans (dRMPs)) under supervision from more senior staff.
'
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 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:
https://lifelancer.com/jobs/view/58e16a2b8706e74714a5f255da3f02cf
Summarized Purpose:
Responsible for the planning, coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Activities include but are not limited to delivery of low complexity safety writing deliverables through achievement of the following tasks: project management, data review, authoring, and quality review. May also support authoring of medium complexity deliverables. Effectively collaborates with various parties, including but not limited to: PVG project team members, wider PPD/Evidera project team members, client contacts and third party vendors.
Essential Functions
- Conducts data review, authoring and quality review tasks on and project
writing deliverables (e.g. line listing reports; Periodic Adverse [Drug] Experience Reports] (PA[D]ERs)).
- May additionally support authoring of medium complexity deliverables (e.g.
(PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), development Risk Management Plans (dRMPs)) under supervision from more senior staff.
- Uses multiple company and client systems. Interacts with project team members and clients.
- Operates in a lead capacity, serving as the primary point of contact for assigned low complexity safety writing deliverables.
- Ensures that assigned safety writing tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.
- Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices and procedures.
- Performs routine project implementation and coordination of activities for
'
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 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:
- Good knowledge of ICH and US aggregate safety reporting formats relating to clinical trials and/or marketed products
- Good attention to detail; good data interpretation and medical-scientific writing skills
- Solid critical thinking and problem solving skills with ability to escalate appropriately
- Ability to manage and prioritize a variety of tasks and meet strict deadlines with modest supervision
- Effective oral and written English language communication skills, including paraphrasing skills
- Good computer skills with the ability to work within multiple systems; proficient in use of Microsoft Office products (including Outlook, Word, and Excel)
- Good understanding of the global regulatory requirements pertaining to pharmacovigilance and the importance of and compliance with procedural documents and regulations
- Ability to maintain a positive and professional demeanor in challenging circumstances
- Ability to work effectively within a team to attain a shared goal
https://lifelancer.com/jobs/view/58e16a2b8706e74714a5f255da3f02cf
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Frontend Developer
IBM,
Remote, Remote
11 hours ago
IntroductionAt IBM, work is more than a job – it’s a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you’ve never thought possible. Are you ready to lead in this new era of technology and...
Accounts Assistant, Asia Pacific
BCD Meetings & Events,
Remote, Remote
1 day ago
Your ideas can drive the future of corporate travel. Join BCD and challenge the status quo!Accounts Assistant, Asia Pacific (Remote)Full time, Bangalore, IndiaThe Accounts Assistant, Asia Pacific reports directly to the Regional Finance Manager and is responsible for the full set of accounts.As an Accounts Assistant, Asia Pacific, you willBe accountable for the full spectrum of accounts, including (accounts payable/accounts...
React.js Developer
Redian Software Global,
Remote, Remote
₹1,000,000
-
₹1,200,000
per year
1 day ago
Note- 1) Only immediate joiners need to apply who can join in max 15 days. WFH avaialbleJob Profile4 to 6 years of experience in UI DevelopmentProficient understanding of JavaScript libraries and frameworks, specifically ReactJSProficient understanding of Flux Architecture (Redux)Proficient understanding of React-BootstrapProficient understanding of Angular JSProficient understanding of web markup, including HTML5, CSS3Experience in working on integration with Magento 2...