Senior Associate, Medical Safety Operations at Acadia Pharmaceuticals

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalsIndustries

Requirements

Bachelor’s degree in life sciences
Minimum of 3 years direct pharmaceutical industry experience dealing with global clinical study individual case safety report processing and reporting preferred; post-approval safety experience highly desired
Detailed knowledge of relevant US, EU, and ICH guidelines, initiatives and regulations governing both clinical studies and post-approval safety
Safety database experience is required (e.g., Argus)
Proficient in MS Word, Excel, PowerPoint, Outlook, and other applicable business software tools

Responsibilities

Perform routine retrospective quality review of the safety data collected to ensure completeness and accuracy. Collaborate with the pharmacovigilance (PV) vendor to address case corrections and trends
Provide case processing guidance to the PV vendor in alignment with existing Mirum standards
Review case metrics to ensure cases processed by the PV vendor are processed and exchanged within the agreed upon timelines
Oversee and support reconciliation of safety data from various sources
Oversee submission of expedited safety reports by the PV vendor and clinical contract research organizations; escalate and document late regulatory authority submissions
Generate listing from Safety Database (Argus) or OBIEE as needed
Responsible for interdepartmental collaboration, such as, but not limited to Quality Assurance, Clinical Operations, Regulatory Affairs on obtaining additional information as needed by PV vendor
Manage and/or support system access (e.g. EDC, Argus etc.) along with periodic review of user access

Skills

Key technologies and capabilities for this role

PharmacovigilanceICSR ManagementArgusOBIEEEDCSafety Data ReconciliationVendor OversightQuality ReviewRegulatory SubmissionsCase Processing

Questions & Answers

Common questions about this position

What is the salary range for this position?

The salary range is $146,000 to $151,000 USD, determined based on skill set, years of experience, and geographic location. This reflects the base salary only and does not include bonus, equity, or benefits.

Is this role remote or hybrid?

The position is hybrid.

What experience and skills are required for this role?

Minimum of 3 years direct pharmaceutical industry experience with global clinical study individual case safety report processing and reporting is preferred, along with detailed knowledge of US, EU, and ICH guidelines. A Bachelor’s degree in life sciences and safety database experience are required, with proficiency in MS Word, Excel, PowerPoint, and Outlook.

What is the company culture like at Mirum Pharmaceuticals?

Mirum is collaborative, creative, and made up of experienced professionals who embody values of care, be real, get it done, and have fun, seriously.

What makes a strong candidate for this Senior Associate role?

Candidates with at least 3 years of direct pharmaceutical industry experience in global clinical study ICSR processing, post-approval safety experience, knowledge of US/EU/ICH guidelines, a life sciences degree, and safety database proficiency stand out.

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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