Job Summary
The Director of Pharmacovigilance is responsible for guiding the pharmacovigilance team, managing all safety-related functions for products throughout their lifecycle, from clinical development to post-marketing phases. This role is vital in ensuring patient safety and regulatory compliance.
Responsibilities
- Oversee signal detection and medical safety monitoring during clinical trials.
- Ensure adherence to both national and international safety regulations.
- Lead the pharmacovigilance team in safety-related activities and product assessments.
- Facilitate safety reporting and manage regulatory submissions effectively.
Qualifications
- Doctorate Degree (MD) is essential.
- Minimum of 10 years’ experience in clinical safety.
- In-depth knowledge of the product lifecycle and safety reporting processes.
- Familiarity with regulatory requirements regarding pharmacovigilance.
Amneal India provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
