425618 Director - Safety Writing (Open)

Job Summary

The Director of Safety Writing is responsible for leading the safety writing team and ensuring the accurate, clear, and compliant preparation of Aggregate Reports and Risk Management Plans. This role requires a thorough understanding of regulatory guidelines and the ability to apply leadership to build a best-in-class capability that delivers the organizational business goals relevant to safety writing. The Director will oversee the efficient preparation of high-quality, strategically aligned safety writing deliverables and lead a global team of medical writers.

Responsibilities

• Accountable for all safety writing deliverables produced by the Medical Writing function.
• Lead and manage line reports, including hiring, training, professional development, performance evaluations, and adherence to departmental procedures and health authority regulations.
• Define and execute strategies for recruitment of top talent and inspire commitment to a future vision aligned with organizational goals.
• Demonstrate quality decision-making and creative problem resolution with significant impact on operations and processes.
• Lead process improvement, training, quality, and compliance initiatives.
• Act as an industry thought leader and influential partner to form beneficial partnerships with external organizations to meet company objectives.

Qualifications

• Education: Master’s degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.). A degree in Medicine, Dentistry, Physiotherapy, or Experimental Medicine is advantageous.
• Experience: Minimum of 18 years of total experience, with at least 10 years in safety writing within the pharmaceutical industry or a large Contract Research Organization, demonstrating leadership.
• Regulatory Knowledge: Expertise in applying FDA, EU, and ICH guidelines for pharmacovigilance in clinical trials and post-marketing.
• Skills: Strong negotiation skills, strategic planning, organizational skills, and outstanding knowledge of written and spoken English.
• Mentorship: Ability to mentor and select essential information, ensuring logical flow, clarity, and accuracy appropriate for target audiences.

Preferred Skills

• Experience working in matrix/multicultural settings and diverse environments, particularly with hybrid teams.
• Highly pragmatic with strong problem-solving abilities.

Experience

• Minimum of 18 years of total experience, with at least 10 years in safety writing, preferably in the pharmaceutical industry or large Contract Research Organizations.

Environment

• Work Type: Full-time
• Work Mode: Hybrid
• Location: Bengaluru Luxor North Tower

Salary

• Estimated Salary Range: ₹14,000,000

Job Start Date

• August 21, 2025

Job End Date

• September 20, 2025