Senior Manager/ Assistant Director, Pharmacovigilance Agreement Manager jobs in United States
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Ionis Pharmaceuticals, Inc. · 8 hours ago

Senior Manager/ Assistant Director, Pharmacovigilance Agreement Manager

Ionis Pharmaceuticals, Inc. is a pioneer in RNA-targeted medicines, dedicated to discovering medical breakthroughs for serious diseases. The Senior Manager/Assistant Director of Pharmacovigilance Agreement Manager will manage legal contracts between pharmaceutical companies, ensuring compliance with regulatory requirements and collaborating with legal and drug safety teams.

BiotechnologyHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

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

Qualification

Pharmacovigilance knowledgeContract experienceRegulatory awarenessAnalytical skillsMicrosoft WordMicrosoft ExcelCommunication skills

Required

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

Preferred

Strong understanding of drug safety principles, adverse event reporting, and risk management practices
Familiarity with legal contracts, terms and conditions, and negotiation strategies
Knowledge of global regulatory requirements related to drug safety reporting
Excellent written and verbal communication to effectively interact with diverse stakeholders
Ability to analyze complex safety data and assess potential risks associated with drug products

Benefits

Ionis offers an excellent benefits package!

Company

Ionis Pharmaceuticals, Inc.

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For three decades, Ionis has invented medicines that bring better futures to people with serious diseases.

H1B Sponsorship

Ionis Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (5)
2023 (3)
2022 (5)
2021 (5)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$2.45B
2025-11-13Post Ipo Debt· $700M
2024-09-09Post Ipo Equity· $500.3M
2023-06-06Post Ipo Debt· $500M

Leadership Team

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Brett P. Monia
Chief Executive Officer
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Eric Bastings
Senior Vice President, Development Strategy
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Company data provided by crunchbase