Senior Manager/ Assistant Director, Pharmacovigilance Agreement Manager

Ionis • Carlsbad, CA

2d

About The Position

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! SENIOR MANAGER/ ASSISTNAT DIRECTOR, PHARMACOVIGILANCE AGREEMENT MANAGER SUMMARY: This position manages and oversees legal contracts between pharmaceutical companies, outlining the responsibilities and procedures for sharing safety data related to drugs, ensuring compliance with regulatory requirements regarding adverse event reporting and risk assessment, while collaborating with legal and drug safety teams to negotiate and maintain these agreements.

Requirements

• Minimum five years of working experience within the pharmaceutical industry and minimum five years within pharmacovigilance.
• Degree / Advanced degree in medicine or in life sciences or equivalent experience e.g. Physician, Pharmacist, Nurse.
• Excellent communication skills including proficiency in verbal and written English.
• Proficiency in Microsoft Word and Excel

Responsibilities

• Contract drafting and negotiation : Develop and review pharmacovigilance agreements (PVAs) with internal and external stakeholders, including contract terms regarding data exchange, reporting timelines, safety monitoring protocols, and regulatory compliance.
• Stakeholder management : Collaborate with internal and external stakeholders, including legal teams, drug safety departments, and partner companies, to address PV concerns and maintain effective communication.
• Ongoing management : Support ongoing management and periodic updating of pharmacovigilance agreements including revising existing agreements or establishing new ones and updating contact lists and appendices.
• Maintain PVA documentation : Maintain a list of all PVAs in Smartsheet. This includes being Admin for the Smartsheet and performing Admin responsibilities such as back-ups. Maintain accurate records of pharmacovigilance agreements including related documentation. Oversee PV Partner compliance to ensure PVA safety operations obligations are being meet by both parties.

Benefits

• Ionis offers an excellent benefits package!
• Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our employee spotlight-,Benefits,-Employees are rewarded

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 1,001-5,000 employees