Thermo Fisher Scientific Inc is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of 13 billion USD, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management.
Post : Safety Writer II
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 safety writing deliverables ranging from low to medium complexity through achievement of the following tasks: project management, data review, authoring, and quality review. May also support authoring of higher 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 function
• Conducts data review, authoring, and quality review tasks on, and project manages a wide range of clinical trial and marketed product safety writing deliverables. These include low complexity (e.g. line listing reports; Periodic Adverse [Drug] Experience Reports (PA[D]ERs)) and moderate complexity (e.g. Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), development Risk Management Plans (dRMPs)) deliverables.
• May additionally support authoring of high complexity (Risk Management Plans (RMPs), marketing authorisation dossier content, customized safety writing deliverables and regulatory authority assessment report responses) deliverables 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 safety writing deliverables. Provides assistance in the development of program and departmental procedural documents. Mentors less experienced staff.
• Ensures that assigned safety writing and project management 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.
• Participates in departmental initiatives
• Performs routine project implementation and coordination activities for assigned safety writing projects, including leading kick-off meetings, managing communications and data requests, participating in client meetings, audits and inspections, and reviewing metrics and budgets.
Candidate Profile
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 5+ 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 :
• Comprehensive knowledge and experience of ICH and US aggregate safety reporting formats relating to clinical trials and/or marketed products
• Thorough attention to detail; strong data interpretation and medical-scientific writing skills
• Strong critical thinking and problem solving skills with ability to evaluate and escalate appropriately
• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
• Skilled at complex project administration including budget activities and forecasting
• Strong oral and written English language communication skills, including paraphrasing skills
• Solid computer skills with the ability to work within multiple systems; proficient in use of Microsoft Office products (including Outlook, Word, and Excel)
• In-depth 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
Additional Information
Experience : 5+ years
Qualification : Bachelor's degree
Location : Bengaluru, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 10th November, 2023
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