Senior Medical Director, Pharmacovigilance and Safety
New
O
Oruka TherapeuticsBiotechnology
Remote or Hybrid if located near Waltham, MA officeFull-TimeSenior
Salary$306,000 to $343,000
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Job Details
- Experience
- Minimum of 6 years of safety experience within the pharmaceutical industry.
- Required Skills
- Risk Management
Requirements
- Medical degree (MD/DO or equivalent) with completed residency.
- Minimum of 6 years of safety experience within the pharmaceutical industry.
- Strong expertise in global pharmacovigilance regulations and requirements.
- Proficiency with safety surveillance systems and tools (e.g., Argus, MedDRA, Veeva Vault).
- Demonstrated ability to work effectively in a dynamic, cross-functional team environment.
- Excellent leadership, analytical, and communication skills.
- Willingness to travel up to 20% of the time if working remotely.
Responsibilities
- Develop and lead product safety surveillance strategies and identify emerging clinical safety issues.
- Conduct routine and ad hoc reviews of safety data and monitor for safety signals.
- Oversee expedited safety reporting, including medical review of ICSRs and SUSARs.
- Provide medical safety guidance to clinical study teams, investigators, and internal stakeholders.
- Lead the preparation of safety-related aggregate reports and regulatory documents such as Investigator's Brochures, DSURs, and RMPs.
- Represent Pharmacovigilance in correspondence and meetings with the FDA and global regulatory authorities.
- Oversee pharmacovigilance vendors and ensure quality and performance standards are met.
- Support inspection readiness and represent the function during audits and due-diligence activities.
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