Associate Director Drug Safety & PV Operations

Acadia Pharmaceuticals Inc.; California, San Diego (MO, CA); Hybrid; USD 163,000 - 205,000; Full time

Job summary

An established industry player is seeking an Associate Director for Drug Safety and Pharmacovigilance Operations. This pivotal role involves ensuring compliance and safety for clinical and marketed products through operational excellence. The ideal candidate will collaborate with cross-functional teams, manage vendor partnerships, and oversee safety reporting processes. With a focus on continuous improvement, this position offers a unique opportunity to lead in a hybrid work environment. If you are passionate about advancing healthcare solutions and have a strong background in pharmacovigilance, this role is an exciting chance to make a significant impact.

Benefits

Discretionary bonus

Equity awards

Flexible work hours

Health insurance

Retirement plan

Paid time off

Professional development

Remote work options

Qualifications

• 8 years of experience in the pharmaceutical or biotech industry.
• Deep understanding of FDA, EU, ICH guidelines.
• Experience with Individual Case Safety Reports (ICSR).

Responsibilities

• Oversee safety information processing and reporting.
• Ensure compliance with global regulations and ICH guidelines.
• Manage vendor partnerships for safety reporting.

Skills

Pharmacovigilance

Regulatory Compliance

Project Management

Interpersonal Skills

Communication Skills

Education

Bachelor's degree in life sciences

Tools

MedDRA

ARGUS

Microsoft Word

Microsoft Excel

Job description

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson's disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit us atAcadia.comand follow us onLinkedInandX.

Position Summary

The Associate Director, Drug Safety and Pharmacovigilance Operations is critical in ensuring the safety and compliance of Acadia's clinical and marketed products by driving operational excellence across global pharmacovigilance (PV) activities. Acting as a key representative of Safety Operations, this role collaborates closely with the Safety Physician and cross-functional stakeholders to monitor product safety, manage vendor partnerships, and ensure timely regulatory submissions. The individual contributes to identifying safety signals and risk management strategies, oversees the execution of safety reporting processes, and champions continuous improvement across PV systems and procedures. This position requires a deep understanding of global PV regulations, a proactive approach to compliance, and the ability to lead through collaboration and influence.

**Please note that this position is based in San Diego, CA., or Princeton, NJ. Acadia's hybrid model requires this role to work on average in our office three days per week.**

Primary Responsibilities

• Participates in setting the direction of PV operational activities to ensure a cost-effective and scalable PV system is in place.


• Provides oversight of safety information processing, reconciliation, and reporting by outsourced vendors, including the review of Individual Case Safety Reports (ICSR) and case processing metrics.


• Management of aggregate reports, including the Development Safety Update Report (DSUR).


• Participates in the development and management of the Pharmacovigilance System Master File (PSMF).


• Liaises with DSP Quality Standards and Training (QST) in reviewing Key Performance Indicators (KPIs), including case quality, reporting, and workflow metrics to assess vendor performance, and takes appropriate action.


• Liaises cross-functionally to ensure needed PV requirements are in the contracts of other vendors receiving safety information (e.g., Commercial) and ensures appropriate procedures and processes are in place for the receipt and reconciliation of such information.


• Monitors global regulatory intelligence to ensure DSP requirements with safety reporting


• Liaises with global teams to execute deliverables, such as study deliverables, aggregate reporting, and post-marketing activities.


• Acts as safety lead for various ACADIA studies to ensure all PV activities are complete and compliant.


• In collaboration with Regulatory Affairs and/or Contract Service Provider, ensures timely submission of expedited and aggregate safety reports to Regulatory Authorities.


• Develops, reviews, and updates drug safety forms and templates, harmonizing them with relevant clinical operation forms and templates (e.g., SAE data collection form, PADER template, etc.).


• If required, participate in the management of safety data exchange agreements with business partners.


• Participate in strategic planning, workflow development, audits, and regulatory inspections.


• Updates key documents including Safety Management Plans, Vendor Oversight Plans, Safety Reporting Forms, narratives, AOSE templates, and other safety-related documentation as needed


• Ensures training of appropriate cross-functional personnel and external groups in drug safety principles and practices.


• Identifies and develops process improvement strategies and communicates project status updates.


• Ensures compliance with global regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements.


• Other duties as assigned.

Education/Experience/Skills

Bachelor's degree in life sciences or related field. Targeting 8 years of progressive experience in the pharmaceutical or biotech industry, with the majority in Pharmacovigilance. Must have knowledge of relevant FDA, EU, ICH guidelines, initiatives, and regulations governing Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology, and knowledge of Clinical Trial guidelines (GCP) and regulations). An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Knowledge of Individual Case Safety Reports (ICSR) management processes, including case receipt, processing, medical review, and regulatory submission.


• Extensive knowledge of DSUR.


• Strong knowledge of MedDRA and common safety databases (ARGUS or ARISg).


• Demonstrated technical, administrative, and project management capabilities.


• Strong interpersonal, organizational, and workload planning skills and excellent verbal and written communication skills.


• Adaptable to changing priorities.


• Proven ability to manage through vision setting and constructive feedback.


• Proficient computer skills, including Microsoft Word and Excel.


• Skilled at negotiating with business partners or management and influencing senior-level leaders regarding matters of significance to the department or segments of the organization.


• Adept at creating and communicating a clear vision among team members, effectively aligning resources to achieve functional area goals.

Physical Requirements

This role involves regular standing, walking, sitting, and using hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-SW1 #LI-HYBRID

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range

$163,600—$204,500 USD

EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply - especially if the reason you are the best candidate isn't exactly as we describe it here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia's career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete ourReasonable Accommodation Request Formor contact us [e-mail]858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

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Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. ("Acadia"). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.