Current jobs related to Safety Writer - Remote - Thermo Fisher Scientific
-
Safety Writer Ii
2 weeks ago
Remote, India Thermo Fisher Scientific Full time**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office About Thermo Fisher Scientific Inc. Thermo Fisher Scientific Inc. is a global leader in the life science sector, providing world-class solutions to pharmaceutical companies, biotech companies, and Clinical Research Organizations (CROs). As the trusted partner of some of the most...
-
Medical Writer Ii
3 weeks ago
Remote, India Parexel Full timeParexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and...
-
Medical Writer Ii
4 weeks ago
Remote, India Parexel Full timeParexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and...
-
Medical Writer I
4 weeks ago
Remote, India Parexel Full timeParexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and...
-
Content Writer
2 weeks ago
Remote, India LugBee Full timeLugBee is a convenient luggage storage service. LugBee, through its online marketplace, connects travellers with local businesses, stores, shops, cafes, hotels, etc., to serve luggage storage in many cities. With LugBee, users can search, compare and book storage services in a partner store easily. We provide a security tag and insurance against loss/theft...
-
Medical Writer Ii
4 weeks ago
Remote, India Syneos Health Clinical Full time**Description** **Medical Writer II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...
-
Principal Medical Writer
2 weeks ago
Remote, India Syneos Health Clinical Full time**Description** **Principal Medical Writer** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...
-
Medical Writer I
5 days ago
hybrid/remote, india myGwork Full timeThis job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Job Purpose: Responsible for management of scheduled and unscheduled aggregate reports including but not limited to...
-
Medical Writer I
1 day ago
hybrid/remote, india myGwork Full timeThis job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Job Purpose: Responsible for management of scheduled and unscheduled aggregate reports including but not limited to...
-
Freelance Content Writer
3 weeks ago
Remote, India Orchard ed tech Full time**Freelance Content Creator - OSHA Training** **Position**: Freelance Content Creator - OSHA Training **Location**: Remote **Duration**: Project-Based **About Us**: **Key Responsibilities**: - **Content Creation**: Develop clear, engaging, and informative OSHA training content, including scripts, video narrations, quizzes. - **Research & Compliance**:...
-
Medical Writer I
2 weeks ago
Remote, India Syneos Health Clinical Full time**Description** **Medical Writer I** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...
Safety Writer
1 month ago
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
manages a range of low complexity clinical trial and marketed product safety
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.
Development Safety Update Reports (DSURs), Periodic Safety Update Reports
(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
assigned safety writing projects, including managing communications and data requests, and participating in kick-off meetings, client meetings, audits and inspections.
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
