Senior PV Associate II at Acadia Pharmaceuticals

Conshohocken, Pennsylvania, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalIndustries

Requirements

Bachelor’s degree in relevant scientific discipline. Clinical experience (e.g. RN, BSN, or PharmD) is preferred but not required
Minimum of 3 years of relevant experience in postmarketing pharmacovigilance
Experience with ICSR processing, narrative writing and quality review
Working knowledge of global pharmacovigilance regulations (e.g., ICH E2A/B, FDA, EMA)
Familiarity with safety databases (e.g., Argus, ARISg), MedDRA and WHO Drug coding
Strong understanding of safety and pharmacovigilance principles

Responsibilities

Assist with oversight of pharmacovigilance vendor activities including but not limited to assessment, evaluation, tracking and reconciliation of safety information
Perform retrospective and in-line quality checks (QC) to ensure proper coding and processing of post-marketing reports which includes tracking and trending for issues as well as remediation effectiveness
Create and utilize trackers to assist team in monitoring vendor KPIs
Provide review of Individual Case Safety Reports [ICSRs], including case narratives, causality assessments and coding for assigned products
Ensure compliance with the required timelines for global safety submissions and assist with other PV compliance activities, as required
Participate in PV safety team and safety vendor meetings
Responsible for distributing and tracking meeting minutes with vendors and monthly reports
Assisting with providing safety information when requested by management
Ensure adherence to global regulations, company SOPs, and best practices in postmarketing safety
Assist with inspection readiness and support audits or health authority inspections as needed
Other duties as assigned

Skills

Key technologies and capabilities for this role

PharmacovigilanceDrug SafetyPostmarketing SurveillanceAdverse Event ReportingRegulatory ReportingCase ProcessingSignal DetectionRisk Management

Questions & Answers

Common questions about this position

What is the work arrangement for this position?

The role is hybrid, requiring 3 days a week in the Conshohocken office.

What are the main responsibilities of the Senior PV Associate II?

The role involves assisting with oversight of pharmacovigilance vendor activities, performing quality checks on post-marketing reports, creating trackers for monitoring vendor KPIs, and reviewing ICSRs including narratives, causality assessments, and coding.

What does the company culture at Madrigal emphasize?

Madrigal is building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration.

Is the salary specified for this role?

This information is not specified in the job description.

What experience is needed to excel in this position?

Strong candidates will have expertise in pharmacovigilance, including ICSR review, vendor oversight, quality checks, coding, causality assessments, and ensuring regulatory compliance and timelines.

Acadia Pharmaceuticals

Develops therapies for neurological disorders

About Acadia Pharmaceuticals

Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia differentiates itself by targeting areas with significant unmet medical needs, ensuring that their products address critical health challenges. Their goal is to improve the quality of life for patients suffering from these disorders while also promoting diversity, equity, and inclusion within their operations.

Dallas, TexasHeadquarters

1993Year Founded

$813.4MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Paid Vacation

Paid Holidays

Paid Sick Leave

Paid Parental Leave

Tuition Reimbursement

Risks

Increased competition in CNS drug market may impact Acadia's market share.

Potential clinical trial delays could affect drug approval timelines.

Dependence on partnerships poses risks if collaborations face challenges or dissolve.

Differentiation

Acadia focuses on CNS disorders with unmet medical needs, like Parkinson's and Rett syndrome.

The company has a strong R&D foundation, developing innovative small molecule drugs.

Acadia's strategic partnerships enhance its research capabilities and market reach.

Upsides

Acadia's collaboration with Saniona expands its portfolio with SAN711 for neurological disorders.

Health Canada's approval of Daybue boosts Acadia's presence in the Canadian market.

The rise of personalized medicine aligns with Acadia's targeted therapy approach.

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