Associate Director, Drug Safety & Pharmacovigilance
Job Description
Please note that this position is based in either San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
Position Summary
Responsible for providing input with pharmacovigilance operational activities for all Acadia products. Acts on behalf of Safety Operations for Acadia clinical programs. Collaborates with the Safety Physician to provide necessary information for the identification and investigation of potential safety signals and contribute to the development of risk management and pharmacovigilance plans. Ensures compliance with timely reporting of the adverse events that meet regulatory requirements for submissions to the applicable Regulatory Agencies.
Primary Responsibilities
- Participates in setting direction of PV operational activities to ensure a cost-effective and scalable PV system in place.
- Provides oversight of safety information processing, reconciliation and reporting by outsourced vendors, including the review of Individual Case Safety Reports (ICSR), and review of case processing metrics.
- Management of aggregate reports, including 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 the review of 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 contracts of other vendors in receipt of 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 on execution of 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, and harmonization with relevant clinical operation forms and templates (i.e. SAE data collection form, PADER template etc.).
- Participates in the management of safety data exchange agreements with business partners if required.
- May participate in strategic planning, workflow development, audits and regulatory inspections.
- Updates key documents including Safety Management Plans, Vendor Oversight Plans, Safety Reporting Forms, narratives and 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 communicate 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 progressively experience in the pharmaceutical or biotech industry with majority in Pharmacovigilance. Must have knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation). 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, case processing, medical review and regulatory submission.
- Extensive knowledge of DSUR.
- Strong knowledge of MedDRA and common safety database (ARGUS or ARISg).
- Demonstrated technical, administrative, and project management capabilities.
- Strong interpersonal, organizational and workload planning skills along with 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
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.
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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.
What we offer you (US-Based Employees):
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- Tuition assistance
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 our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 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.
Notice for California Applicants: Please see our California Applicant Privacy Notice within our Privacy Policy.
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.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity
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