O pozici
The Drug Safety Team Lead is responsible for overseeing pharmacovigilance (PV) activities to ensure the safety of patients and compliance with global regulatory requirements. This role provides strategic and operational leadership for safety surveillance across clinical development and post-marketing products. The Drug Safety Team Lead collaborates cross-functionally with Clinical Operations, Regulatory Affairs, Medical Affairs, Quality Assurance, and external partners to ensure high-quality safety reporting and risk management.
Co budeš dělat
- Lead and manage the Drug Safety team, including safety scientists and case processing staff.
- Provide strategic oversight for safety surveillance activities across clinical trials and marketed products.
- Serve as the safety representative on cross-functional project teams.
- Develop and implement pharmacovigilance strategies aligned with company and regulatory requirements.
- Ensure compliance with global pharmacovigilance regulations (FDA, EMA, ICH guidelines, and other regional authorities).
- Maintain inspection readiness and support regulatory audits and inspections.
- Review and approve safety documentation and regulatory submissions
Koho hledáme
- MD, PharmD, PhD, or Master’s degree in life sciences, pharmacy, nursing, or related field.
- 5+ years of experience in pharmacovigilance or drug safety.
- 3+ years of leadership or team management experience preferred.
Benefity
- Flexible Benefit System - budget to be spent on services of your choice
- Competitive bonus structure
- Refer-a-Friend – get a bonus in the employee referral program
- Loyalty rewards
- Wide range of trainings and expert lectures
- Employee share purchase plan
- Pension / Life insurance contribution
- 5 extra days off
- Sick leave salary compensation
- Employee assistance services (professional psychological, financial and legal help)
- Multisport card
