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Sr MD Drug Safety
144184
Posted:
09th
May 2024
- 290000 USD - 360000 USD
- Hayward, United States
- Permanent
Exciting opportunity with a cutting-edge Oncology-focused biotech looking to bring on a Sr. MD, Drug Safety and PV to their seasoned leadership team. If you are looking to join a growing innovative organization with a robust pipeline within the oncology space, this is the position for you!
As the SR. Drug Safety Medical Director, you will play a pivotal role in safeguarding the integrity and safety of our pharmaceutical products. Reporting to the Head of Drug Safety, you will lead and oversee all aspects of drug safety within our organization.
Key Responsibilities:
- Safety Strategy Development: Develop and implement comprehensive safety strategies in alignment with regulatory guidelines for multiple compounds across various stages of development.
- Safety Evaluation: Lead safety assessments by analyzing and interpreting clinical and post-marketing safety data to ensure early detection and mitigation of potential risks.
- Risk Management: Collaborate with cross-functional teams to develop risk management plans and drive proactive risk minimization strategies.
- Pharmacovigilance Leadership: Oversee pharmacovigilance activities, including signal detection, risk-benefit assessments, and safety-related submissions, ensuring compliance with global regulatory requirements.
- Safety Documentation: Contribute to the preparation and review of safety-related documents, including but not limited to periodic safety reports, investigator brochures, and safety sections of regulatory submissions.
- Cross-functional Collaboration: Work closely with clinical development, regulatory affairs, medical affairs, and other relevant departments to integrate safety perspectives into overall product development strategies.
Qualifications and Experience:
- Medical degree with specialized training or certification in drug safety, pharmacovigilance, or a related field.
- Significant experience (8+ years) in pharmaceutical drug safety within a clinical, regulatory, or industry setting. Must have Oncology experience!
- In-depth knowledge of global regulatory requirements and guidelines related to pharmacovigilance and drug safety.
- Strong leadership skills with the ability to effectively manage and collaborate within cross-functional teams.
- Excellent communication skills, both written and verbal, with the capability to articulate complex safety-related information to diverse audiences.
Sarah McGraw
Division Manager