Safety Writer III
Thermo Fisher Scientific · India
- Hybrid
- Full-time
- $120,000 / year
- India
Job highlights
- Plan, coordinate, and deliver safety writing services.
- Manage diverse safety writing deliverables for clinical trials.
- Collaborate with internal teams and external clients.
- Mentor junior staff and lead project initiatives.
- Ensure regulatory compliance in a pharmacovigilance setting.
About the role
Safety Writer III – Make an Impact at Thermo Fisher Scientific
Thermo Fisher Scientific is seeking a Safety Writer III to join our expert team. In this role, you will be instrumental in ensuring operational excellence and making a real difference in patient safety. You will be responsible for the planning, coordination, and delivery of safety writing services for clinical trial and/or marketed product projects. This includes managing projects where Thermo Fisher Scientific acts as a pharmacovigilance functional service provider. You will perform day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Your activities will encompass project management, data review, authoring, quality review, and senior review for safety writing deliverables of varying complexity. You may also provide support for scientific safety services on an ad-hoc basis and will collaborate effectively with various internal and external stakeholders.
What You’ll Do:
- Conduct data review, authoring, quality review, and senior review for a wide range of clinical trial and marketed product safety writing deliverables.
- Project manage deliverables including low complexity (e.g., line listing reports, Periodic Adverse [Drug] Experience Reports (PA[D]ERs)), 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)), and high complexity (Risk Management Plans (RMPs), marketing authorization dossier content, customized safety writing deliverables, and regulatory authority assessment report responses).
- Provide support for scientific safety services on an ad-hoc basis.
- Utilize multiple PPD and client systems and interact with project team members and clients.
- Function in a lead role, serving as the primary point of contact for assigned safety writing deliverables, exercising independent judgment to troubleshoot and resolve project issues, and identifying areas for improvement.
- Mentor less experienced staff.
- Ensure all tasks are conducted in accordance with company policies, procedures, contractual agreements, and applicable regulations.
- Review regulatory/pharmacovigilance publications to stay updated on current regulations, practices, and procedures.
- Participate in departmental initiatives and serve as a subject matter expert in a designated area.
- Perform routine project implementation and coordination activities, including leading kick-off meetings, managing communications and data requests, participating in client meetings, audits, and inspections, and reviewing metrics and budgets.
Education and Experience Requirements:
- Bachelor's or higher scientific degree.
- Minimum of 6 years' experience in authoring and quality control review of DSURs, PBRERs/PSURs, PA(D)ERs, and RMPs for innovative medicinal products.
Knowledge, Skills and Abilities:
- Highly skilled in ICH and US aggregate safety reporting formats for clinical trials and marketed products; knowledge of risk management plans.
- Excellent attention to detail, data interpretation, and medical-scientific writing skills.
- Advanced critical thinking and problem-solving skills with the ability to evaluate and escalate appropriately.
- Great project management skills with the ability to manage multiple projects simultaneously.
- Ability to motivate, mentor, and provide guidance to less experienced staff.
- Excellent complex project administration skills, including budget activities and forecasting.
- Excellent oral and written English language communication skills, including paraphrasing.
- Exceptional computer skills with the ability to work within multiple systems; advanced skills in Microsoft Office products (Outlook, Word, Excel).
- Advanced understanding of global regulatory requirements for pharmacovigilance 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.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.
Key skills/competency
- Safety Writing
- Pharmacovigilance
- Clinical Trials
- Regulatory Affairs
- Project Management
- DSURs
- PSURs/PBRERs
- Risk Management Plans (RMPs)
- ICH Guidelines
- Medical Writing
Skills & topics
- Safety Writer
- Pharmacovigilance
- Medical Writing
- Regulatory Affairs
- Clinical Trials
- DSUR
- PSUR
- PBRER
- RMP
- ICH Guidelines
- Project Management
- Data Review
- Quality Control
- Scientific Writing
- Life Sciences
How to get hired
- Tailor your resume: Highlight your 6+ years of experience authoring and reviewing DSURs, PBRERs/PSURs, PA(D)ERs, and RMPs for innovative medicinal products. Quantify your project management achievements.
- Showcase your skills: Emphasize your expertise in ICH and US aggregate safety reporting, risk management plans, and medical-scientific writing. Mention your advanced critical thinking and problem-solving abilities.
- Demonstrate regulatory knowledge: Detail your advanced understanding of global pharmacovigilance regulations and compliance with procedural documents.
- Prepare for technical questions: Be ready to discuss your experience with PPD and client systems, Microsoft Office Suite, and your approach to data review and quality control.
- Highlight leadership potential: Showcase your mentoring experience and ability to lead projects and serve as a primary point of contact.
Technical preparation
Master ICH and US aggregate safety reporting formats.,Become proficient in risk management plan documentation.,Practice data interpretation and medical-scientific writing.,Strengthen skills in PPD and client pharmacovigilance systems.
Behavioral questions
Describe a time you managed multiple complex projects.,How do you handle strict project deadlines?,Share an example of mentoring a junior colleague.,How do you ensure accuracy in regulated documentation?
Frequently asked questions
- What specific types of safety reports does a Safety Writer III at Thermo Fisher Scientific author and review?
- As a Safety Writer III at Thermo Fisher Scientific, you will author and review a range of safety reports including Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse [Drug] Experience Reports (PA[D]ERs), and Risk Management Plans (RMPs). Your experience should cover these for innovative medicinal products.
- What level of experience is required for the Safety Writer III role at Thermo Fisher Scientific?
- Thermo Fisher Scientific requires a minimum of 6 years of experience for the Safety Writer III position. This experience must specifically include authoring and quality control review of DSURs, PBRERs/PSURs, PA(D)ERs, and RMPs for innovative medicinal products.
- What are the key technical skills needed for a Safety Writer III at Thermo Fisher Scientific?
- Key technical skills include strong proficiency in ICH and US aggregate safety reporting formats, knowledge of risk management plans, excellent medical-scientific writing, data interpretation, and advanced computer skills, particularly with Microsoft Office Suite (Outlook, Word, Excel) and various client systems used in pharmacovigilance.
- How does Thermo Fisher Scientific support patient safety through this role?
- The Safety Writer III plays a crucial role in ensuring patient safety by meticulously planning, coordinating, and delivering accurate and timely safety writing deliverables for clinical trials and marketed products. This includes rigorous data review, authoring, and quality control within a highly regulated environment.
- What is the typical work environment for a Safety Writer III at Thermo Fisher Scientific?
- The work environment for a Safety Writer III at Thermo Fisher Scientific is an office setting, with a standard Monday-Friday work schedule. The role operates within a highly regulated pharmacovigilance setting, requiring adherence to strict timelines and procedures.
- Can a Safety Writer III at Thermo Fisher Scientific mentor other team members?
- Yes, a key aspect of the Safety Writer III role at Thermo Fisher Scientific is to mentor less experienced staff. You will function in a lead role, providing guidance and support to junior team members in addition to managing your own deliverables.
- What kind of projects will a Safety Writer III be involved in at Thermo Fisher Scientific?
- A Safety Writer III will be involved in a wide range of projects, including the delivery of safety writing deliverables for clinical trials and marketed products. This spans from low complexity reports to high complexity regulatory documents, and may also include functional service provider arrangements.