Manager, PV - Safety Writing
Thermo Fisher Scientific · India
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- Hybrid
- Full-time
- $120,000 / year
- India
Job highlights
- Lead drug safety operations for clinical trials.
- Manage aggregate safety reports and RMPs.
- Oversee a team of experienced professionals.
- Ensure regulatory compliance and patient safety.
- Collaborate globally for scientific excellence.
About the role
Manager, Pharmacovigilance Safety Writing
Join Thermo Fisher Scientific as a Safety Writing Manager and lead drug safety operations. Ensure patient safety and regulatory compliance in clinical trials by managing and optimizing these critical processes.
What You’ll Do:
- Manage the delivery of global aggregate safety reports, risk management plans (RMPs), regulatory authority assessment report responses, and custom safety reports for developmental and marketed products.
- Ensure the team has adequate resources to deliver services according to company policies, contractual agreements, and applicable regulations.
- Maintain effective communication with other functional groups regarding safety writing activities.
- Prepare and present proposals and bids for the Safety Writing Team.
- Participate in client and internal meetings, audits, and regulatory authority inspections.
- Engage in departmental initiatives and task forces for process improvement and department management.
- Stay updated on current regulations and practices by reviewing regulatory/pharmacovigilance publications.
- Provide input on Pharmacovigilance procedural documents.
- Participate in meetings to discuss quality, budgetary, or operational aspects of safety writing services.
- Manage a team of experienced professionals, including interviewing, hiring, professional development, goal setting, performance management, coaching, mentoring, employee counseling, and separations.
- Approve salary administration, hiring decisions, corrective actions, and terminations.
- Review and approve time records, expense reports, and leave requests.
Education and Experience:
- Bachelor's or higher scientific degree.
- Over 5 years of previous safety writing experience.
- 1+ year of leadership responsibility.
- An equivalent combination of education, training, and experience may be considered.
Knowledge, Skills and Abilities:
- Excellent knowledge of risk management plans and ICH/US aggregate safety reporting formats for clinical trials and marketed products.
- Exceptional attention to detail, data interpretation, and medical-scientific writing skills.
- Proficient time management and project management skills.
- Proficiency in Microsoft Office products and safety databases.
- Excellent oral and written English communication skills.
- Strong attention to detail and accuracy.
- Excellent critical thinking, problem-solving, and decision-making abilities.
- Advanced understanding of global regulatory requirements for pharmacovigilance and compliance with procedural documents and regulations.
Working Conditions and Environment:
- Office environment with standard office equipment.
- Daily exposure to high pressure and intense concentration.
- Daily interactions with clients and associates.
- Occasional long and varied hours.
- Occasional domestic and/or international travel required.
Why Join Us?
Become part of a global team at Thermo Fisher Scientific that values passion, innovation, and scientific excellence. Experience an environment where collaboration and development foster everyday growth, and your contributions make a significant impact. Apply today to help us deliver tomorrow's breakthroughs.
Key skills/competency
- Pharmacovigilance
- Safety Writing Manager
- Aggregate Safety Reports
- Risk Management Plans (RMPs)
- Regulatory Compliance
- Clinical Trials
- ICH Guidelines
- Team Management
- Medical Writing
- Regulatory Affairs
Skills & topics
- Pharmacovigilance
- Safety Writing
- Drug Safety
- Regulatory Affairs
- Clinical Trials
- Manager
- Team Lead
- Medical Writing
- ICH Guidelines
- Risk Management
- Aggregate Reports
- Microsoft Office
- Safety Databases
- Problem Solving
- Leadership
How to get hired
- Tailor your resume: Highlight your 5+ years of safety writing and 1+ year of leadership experience, aligning keywords with the job description's requirements for pharmacovigilance and regulatory compliance.
- Craft a compelling application: Clearly articulate your experience in managing aggregate safety reports, RMPs, and leading teams within a clinical trial or drug development context.
- Prepare for interviews: Be ready to discuss your understanding of global regulatory requirements, ICH guidelines, and your approach to team management and process improvement.
- Research Thermo Fisher Scientific: Understand their commitment to scientific excellence and how your role contributes to patient safety and delivering breakthroughs.
Technical preparation
Master ICH and US aggregate safety reporting.,Practice writing RMPs and safety reports.,Familiarize with common safety databases.,Review global pharmacovigilance regulations.
Behavioral questions
Describe managing a team of writers.,How do you ensure regulatory compliance?,How do you handle high-pressure situations?,Give an example of process improvement.
Frequently asked questions
- What is the primary responsibility of the Manager, PV - Safety Writing at Thermo Fisher Scientific?
- The primary responsibility is to lead and manage drug safety operations, focusing on the delivery of aggregate safety reports, risk management plans, and ensuring regulatory compliance for both developmental and marketed products within clinical trials.
- What educational background is typically required for the Manager, PV - Safety Writing role?
- A Bachelor's or higher scientific degree is generally required for this role. An equivalency of appropriate education, training, and directly related experience may also be considered.
- How much safety writing experience is needed for this position?
- You will need more than 5 years of previous safety writing experience to possess the knowledge, skills, and abilities necessary for this role. Additionally, at least 1 year of leadership responsibility is required.
- What are the key skills for a Safety Writing Manager at Thermo Fisher Scientific?
- Key skills include excellent knowledge of risk management plans and aggregate safety reporting formats (ICH/US), strong medical-scientific writing, project management, proficiency in safety databases and Microsoft Office, and an advanced understanding of global regulatory requirements in pharmacovigilance.
- What is the work environment like for this role?
- The role is based in a standard office environment with daily exposure to high pressure and intense concentration. It involves regular client interactions and occasional long hours or travel.
- Does Thermo Fisher Scientific offer opportunities for professional development for this role?
- Yes, Thermo Fisher Scientific values development and fosters an environment where it's part of the everyday experience. The role includes managing the professional development of team members.
- How does Thermo Fisher Scientific ensure quality in safety writing services?
- Quality is ensured through adherence to company policies, contractual agreements, applicable regulations, and by maintaining good communication with other functional groups. The role also involves participation in audits and inspections.
- What is the expected travel frequency for the Manager, PV - Safety Writing position?
- Travel is required occasionally, which may include both domestic and international travel, as needed for client meetings or regulatory inspections.