27 days old

Associate Director Drug Safety and Pharmacovigilance Operations

ACADIA Pharmaceuticals
Princeton, NJ 08540
  • Job Code
    118925113
ACADIA Pharmaceuticals

ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.

Position Summary:

Responsible for the safety and pharmacovigilance operational activities for all ACADIA products. Oversee and manage PV vendor(s) to ensure state of compliance. Collaborates with the Safety Physician to provide necessary information for the identification and investigation of potential safety signals and contribute with 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:

  • Leads vendor selection process including identification of other opportunities for outsourcing. Oversees and manages outsourced PV vendor to ensure regulatory compliance and contractual obligations met.
  • Liaise with other departments to ensure needed PV requirements are in contracts of other vendors in receipt of safety information (e.g. Commercial).
  • Assists Safety Physician with obtaining data needed for signal detection and safety oversight.
  • Manages direct reports (including Managers and Safety Specialists), consultants and external partners.
  • Ensures aggregate report schedule is maintained and coordinates the authoring and approval of required aggregate reports Assists in management of budgets (internal/external).
  • Reviews safety sections of clinical documents, including the safety portion of protocols, annual reports, clinical study reports, IB, and other documents.
  • Provides necessary information and guidance to the vendor to ensure proper set-up and configuration of the safety database.
  • Ensures needed wording is in SAE Management Plan covering study-specific SAE workflow between Contract Research Organizations (CROs) and ACADIA.
  • Plans and oversees the implementation of SAE database reconciliation in collaboration with Data Management.
  • Implements PV quality management system including the identification and authoring of required procedural documents.
  • Assists with collection and monitoring of pharmacovigilance compliance.
  • In collaboration with Regulatory Affairs and/or Contract Service Provider, ensures timely submission of expedited 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.)
  • Oversees the appropriate management of safety data exchange agreements with business partners if required.
  • As required, participates in strategic planning, workflow development, audits and inspections,
  • Assists with training appropriate cross-functional personnel and external groups in drug safety principles and practices.
  • Interacts with safety colleagues to identify 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.

Education/Experience/Skills:

Must possess:

  • Bachelors degree in the life sciences or related. An equivalent combination of relevant education and applicable job experience may be considered.
  • Generally 8 years or more in industry with majority in Pharmacovigilance with prior oversight of PV Operations.
  • Solid 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) is essential.
  • Knowledge of Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review and regulatory submission.
  • 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 and lead team 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.

Scope:

Manages segment to achieve goals in accordance with established policies, meet schedules and resolve problems; may provide direction to and review of, managers, supervisors, or employees. Works on abstract problems that may cross functional areas. Interacts with management on matters concerning functional area. Erroneous decisions will have a serious impact on the overall success of functional area and may impact overall company operations.

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. Employee must occasionally lift and/or move up to 15 pounds.


PI118925113

<b>ACADIA Pharmaceuticals</b><br/><br/>ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br/><br/><p style="text-align: center;"><strong>For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.</strong></p> <p><strong><u>Position Summary:</u></strong></p> <p>Responsible for the safety and pharmacovigilance operational activities for all ACADIA products. Oversee and manage PV vendor(s) to ensure state of compliance. Collaborates with the Safety Physician to provide necessary information for the identification and investigation of potential safety signals and contribute with 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.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Leads vendor selection process including identification of other opportunities for outsourcing. Oversees and manages outsourced PV vendor to ensure regulatory compliance and contractual obligations met.</li> <li>Liaise with other departments to ensure needed PV requirements are in contracts of other vendors in receipt of safety information (e.g. Commercial).</li> <li>Assists Safety Physician with obtaining data needed for signal detection and safety oversight.</li> <li>Manages direct reports (including Managers and Safety Specialists), consultants and external partners.</li> <li>Ensures aggregate report schedule is maintained and coordinates the authoring and approval of required aggregate reports Assists in management of budgets (internal/external).</li> <li>Reviews safety sections of clinical documents, including the safety portion of protocols, annual reports, clinical study reports, IB, and other documents.</li> <li>Provides necessary information and guidance to the vendor to ensure proper set-up and configuration of the safety database.</li> <li>Ensures needed wording is in SAE Management Plan covering study-specific SAE workflow between Contract Research Organizations (CROs) and ACADIA.</li> <li>Plans and oversees the implementation of SAE database reconciliation in collaboration with Data Management.</li> <li>Implements PV quality management system including the identification and authoring of required procedural documents.</li> <li>Assists with collection and monitoring of pharmacovigilance compliance.</li> <li>In collaboration with Regulatory Affairs and/or Contract Service Provider, ensures timely submission of expedited safety reports to Regulatory Authorities.</li> <li>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.)</li> <li>Oversees the appropriate management of safety data exchange agreements with business partners if required.</li> <li>As required, participates in strategic planning, workflow development, audits and inspections,</li> <li>Assists with training appropriate cross-functional personnel and external groups in drug safety principles and practices.</li> <li>Interacts with safety colleagues to identify process improvement strategies and communicate project status updates.</li> <li>Ensures compliance with global regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements.</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <p>Must possess:</p> <ul> <li>Bachelors degree in the life sciences or related. An equivalent combination of relevant education and applicable job experience may be considered.</li> <li>Generally 8 years or more in industry with majority in Pharmacovigilance with prior oversight of PV Operations.</li> <li>Solid 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) is essential.</li> <li>Knowledge of Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review and regulatory submission.</li> <li>Strong knowledge of MedDRA and common safety database (ARGUS or ARISg).</li> <li>Demonstrated technical, administrative, and project management capabilities.</li> <li>Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.</li> <li>Adaptable to changing priorities.</li> <li>Proven ability to manage and lead team through vision setting and constructive feedback.</li> <li>Proficient computer skills, including Microsoft Word and Excel.</li> <li>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.</li> <li>Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.</li> </ul> <p><strong><u>Scope:</u> </strong></p> <p>Manages segment to achieve goals in accordance with established policies, meet schedules and resolve problems; may provide direction to and review of, managers, supervisors, or employees. Works on abstract problems that may cross functional areas. Interacts with management on matters concerning functional area. Erroneous decisions will have a serious impact on the overall success of functional area and may impact overall company operations.</p> <p><strong><u>Physical Requirements:</u></strong></p> <p>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. Employee must occasionally lift and/or move up to 15 pounds.</p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/6edjMrCgpGBZS8lwCoK4n"> <p>PI118925113</p>

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Posted: 2020-03-11 Expires: 2020-04-11

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Associate Director Drug Safety and Pharmacovigilance Operations

ACADIA Pharmaceuticals
Princeton, NJ 08540

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