Safety Writer IV
Thermo Fisher Scientific · India
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- Hybrid
- Full-time
- $120,000 / year
- India
Job highlights
- Lead safety writing for clinical trials and marketed products.
- Manage complex regulatory documents and project timelines.
- Collaborate with global teams and clients.
- Ensure pharmacovigilance compliance and patient safety.
- Mentor junior staff and drive departmental initiatives.
About the role
Safety Writer IV - Thermo Fisher Scientific
Join Thermo Fisher Scientific as a Safety Writer IV and contribute to critical pharmacovigilance activities, ensuring patient safety at the forefront of innovation.
About the Role
As a Safety Writer IV, you will be responsible for the planning, coordination, and delivery of safety writing services for clinical trial and/or marketed product projects. You will perform day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Your activities will include project management, data review, authoring, quality review, and senior review for deliverables ranging from low to high complexity. You may also provide support for scientific safety services and lead departmental initiatives.
Key Responsibilities:
- 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, PA(D)ERs), moderate complexity (e.g., DSURs, PSURs/PBRERs, dRMPs), and high complexity (e.g., RMPs, marketing authorization dossier content, regulatory authority assessment report responses).
- Serve as a consultant on higher complexity deliverables and provide support for scientific safety services on an ad-hoc basis.
- Utilize multiple PPD and client systems, interacting effectively with project team members and clients.
- Function in a lead role, serving as the primary point of contact for assigned safety writing deliverables and troubleshooting project issues.
- Support management with delegated oversight of team training and mentoring.
- Ensure all tasks are conducted in accordance with company policies, procedures, contractual agreements, and applicable regulations.
- Stay updated on current regulations, practices, and procedures by reviewing regulatory/pharmacovigilance publications.
- Participate in and lead departmental initiatives, serving as a subject matter expert.
- Perform routine project implementation and coordination activities, including leading kick-off meetings, managing communications, and participating in client meetings, audits, and inspections.
Education and Experience:
- Bachelor's or higher scientific degree.
- Minimum of eight 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.
- Excellent attention to detail, data interpretation, and medical-scientific writing skills.
- Advanced critical thinking and problem-solving abilities.
- Great project management skills with the ability to manage multiple projects simultaneously.
- Ability to motivate, mentor, and provide guidance to less experienced staff.
- Advanced project administration skills, including budget activities and forecasting.
- Excellent oral and written English communication skills.
- Exceptional computer skills with proficiency in Microsoft Office Suite.
- Advanced understanding of global regulatory requirements in pharmacovigilance.
- Ability to maintain a positive and professional demeanor in challenging circumstances.
- Ability to work effectively within a team.
Working Conditions:
- Office environment.
- Daily exposure to high pressure and intense concentration.
- Daily interactions with clients/associates.
- Long, varied hours on occasion.
- Travel required on occasion (domestic and/or international).
Why Join Us?
Join Thermo Fisher Scientific and become part of a global team that values passion, innovation, and scientific excellence. You'll work in an environment where collaboration and development are integral, and your contributions make a real difference in delivering tomorrow's breakthroughs.
Key skills/competency
- Safety Writing
- Pharmacovigilance
- Clinical Trials
- Regulatory Affairs
- DSUR
- PSUR
- PBRER
- Risk Management Plans (RMPs)
- Data Review
- Project Management
Skills & topics
- Safety Writer
- Pharmacovigilance
- Regulatory Writing
- Clinical Trials
- DSUR
- PSUR
- PBRER
- Risk Management Plans
- Aggregate Safety Reporting
- Medical Writing
- ICH
- US Regulatory
- Data Review
- Quality Control
- Project Management
- Biotechnology
- Pharmaceuticals
- Scientific Writing
How to get hired
- Tailor your resume: Highlight your 8+ years of experience authoring DSURs, PBRERs/PSURs, PA(D)ERs, and RMPs, emphasizing ICH and US aggregate safety reporting.
- Showcase project management skills: Detail your experience managing multiple complex safety writing projects from initiation to completion, including data review and quality control.
- Quantify your impact: Provide examples of how you've ensured compliance with regulations, improved processes, or mentored junior staff in pharmacovigilance settings.
- Prepare for technical questions: Be ready to discuss your deep understanding of global regulatory requirements, risk management plans, and experience with various pharmacovigilance systems.
- Demonstrate leadership potential: Highlight instances where you've served as a primary point of contact, resolved project issues, or led departmental initiatives.
Technical preparation
Master ICH and US aggregate safety reporting formats.,Demonstrate expertise in DSUR, PBRER/PSUR, PA(D)ERs, RMPs.,Become proficient in multiple pharmacovigilance systems.,Deepen understanding of global regulatory requirements.
Behavioral questions
Describe a complex safety report you managed.,How do you handle tight deadlines and high pressure?,Share an experience mentoring a junior colleague.,How do you ensure accuracy in regulatory documents?
Frequently asked questions
- What specific report types are critical for the Safety Writer IV role at Thermo Fisher Scientific?
- For the Safety Writer IV position at Thermo Fisher Scientific, critical report types include Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs), Periodic Adverse [Drug] Experience Reports (PA(D)ERs), and Risk Management Plans (RMPs). Your resume should clearly detail extensive experience in authoring and quality control review of these documents for innovative medicinal products.
- How important is project management experience for a Safety Writer IV at Thermo Fisher Scientific?
- Project management is a key responsibility for the Safety Writer IV. You will be expected to manage multiple safety writing projects simultaneously, including leading kick-off meetings, managing communications, and ensuring timely delivery of all project phases. Strong project management skills are essential for success in this role.
- What level of regulatory knowledge is expected for the Safety Writer IV position?
- An advanced understanding of global regulatory requirements pertaining to pharmacovigilance is expected. This includes highly skilled knowledge of ICH and US aggregate safety reporting formats for both clinical trials and marketed products, as well as familiarity with risk management plans. Keeping up-to-date with current regulations and practices is crucial.
- Does the Safety Writer IV role involve mentoring or leading other team members at Thermo Fisher Scientific?
- Yes, the Safety Writer IV role includes responsibilities related to leadership and mentoring. You may provide guidance and training to less experienced staff, support management with delegated oversight of team training, and serve as a subject matter expert. This position also functions in a lead role for assigned deliverables.
- What kind of systems and software will a Safety Writer IV at Thermo Fisher Scientific use?
- A Safety Writer IV will use multiple PPD and client systems. Advanced computer skills are required, with a strong emphasis on proficiency in Microsoft Office products, including Outlook, Word, and Excel. You should be comfortable working within various integrated systems common in the pharmacovigilance field.
- Is travel required for the Safety Writer IV position at Thermo Fisher Scientific?
- Travel may be required on occasion for the Safety Writer IV position, both domestically and internationally. While not a primary daily duty, the role may necessitate occasional travel for client meetings, audits, inspections, or other project-related activities.