Sr. Pharmacovigilance Scientist (PV Manager)

Sr.  Pharmacovigilance Scientist/PV Manager Newark, CA

Rain Oncology is committed to building a passionate team of core business leaders to execute on our vision to identify and execute on the development of novel therapeutic avenues for the treatment of cancer. The personality of Rain will always be focused on entrepreneurs with autonomy to build their respective teams in a flat organizational structure. We recognize that a collaborative team needs time together in the office and expect regular days per week on site.

The Senior Pharmacovigilance (PV) Scientist serves as a product lead for Pharmacovigilance activities within the Global Drug Safety and Pharmacovigilance function. He/she is responsible for overseeing and leading the process for safety signal management activities, aggregate reports, assist in responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Rain-sponsored clinical trial medical activities. He/she also serves as a Subject Matter Expert for Drug Safety and Pharmacovigilance and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product-specific information.

• Leads the signal management process (i.e., signal tracking, leading review meetings, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.
• Collaborates with Clinical Development and Clinical Science teams for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.) safety committee management, data analysis, signal detection, ad-hoc requests and other product activities, as assigned.
• Leads process for responding to safety questions from regulatory authorities.
• Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
• Leads and collaborates with Aggregate Reports on strategy, review, and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).

Qualifications

• Bachelor’s Degree in biologic or natural science; or health case discipline. Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred or extensive PV Experience.
• 4+ years safety experience, with a minimum of 2 years Pharmacovigilance Scientist experience (with a PharmD) or 6+ years without a PharmD.
• Ideally looking for a combination of experience including experience in aggregate safety reports and safety signal management. Strong background in clinical trial drug safety is required
• Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
• Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Clinical Science, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
• Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less experienced PV Scientist staff.
• Applies clinical judgment to interpret case information.
• Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts.
• Strong organizational skills, including the ability to prioritize independently with minimal supervision.
• Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.

The pay range that the Company reasonably expects to pay for this position is $140,000 - $171,000; the pay ultimately offered may vary based on objective considerations, including job-related knowledge, skills, experience, and education. An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of financial, health and wellness benefits, dependent on the position offered.

Local Candidates Only**