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Serving as Senior Pharmacovigilance Director for Global Development
vor 1 Monat
This is an extraordinary opportunity to take on a challenging leadership position at Organon, focusing on drug safety and pharmacovigilance.
As a Senior Pharmacovigilance Director for Global Development, you will be responsible for driving the safety strategy for assigned products. This includes ensuring the scientific foundation of benefit-risk profiles, risk communication, and compliance with global regulations.
Your Key Responsibilities Will Include:
- Leading the development and implementation of safety strategies for medicinal products and medical devices.
- Fostering collaboration with cross-functional teams to align safety strategies with company objectives.
- Providing expert input on safety tasks in clinical trials, including protocol review, SUSAR, ASR/DSUR, safety reporting, and informed consent forms.
- Maintaining oversight of SS process-related vendor activities and ensuring compliance with regulations.
- Developing and maintaining relationships with key stakeholders, including regulatory agencies and health authorities.
Requirements and Qualifications
To succeed in this role, you will need a medical degree, ideally with experience in clinical drug safety and pharmacovigilance. You must have at least 10 years of experience in the pharmaceutical industry, with 5-10 years in drug safety and pharmacovigilance. Your expertise should include extensive knowledge of PV deliverables, standards, and processes at a global level, as well as experience in pharmacoepidemiology and signal management.
You will also need excellent verbal and written communication skills, analytical skills, and demonstrated leadership abilities. Ability to build strong relationships, represent the company professionally, and interpret global drug safety regulations are essential.
A bachelor's or master's degree in a relevant field would be beneficial. Experience managing people and working in matrix team settings is highly valued.
What We Offer
At Organon, we are committed to providing our employees with opportunities for growth and development. As a Senior Pharmacovigilance Director for Global Development, you can expect a competitive salary, ranging from $120,000 to $180,000 per annum, depending on your location and qualifications. Our benefits package includes comprehensive health insurance, paid vacation time, and opportunities for professional growth and advancement.
