Associate Director, Drug Safety

Job Description

Lead and develops the necessary processes to ensure high quality individual case and aggregate safety reporting. Interpret PV regulations related to drugs, vaccines, biologics, and devices and provide expert guidance. Collaborate with internal and external stakeholders with processes that ensure compliance with local and global PV regulations.

• Ensure that PV activities are supported by robust procedures (e.g., SOPs, User manuals, etc.).

• Promote understanding and education of PV regulation with all of company’s business units to ensure compliance and patient safety.

• Assist in the development and leadership of team members.

• Develop and implement strategies aiming to promote the mission and vision of organization.

• Lead core activities tied to individual adverse experience cases and periodic reports to ensure standardization and optimization from both a system and process prospective.

• Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits.

• Lead efforts to improve departmental efficiencies.

• Monitor metrics are tracked to demonstrate compliance with PV regulation and timelines.

• Collaborate with and maintain effective working relationships with International Pharmacovigilance community and external customers to ensure regulatory compliance for both expedited and periodic reports.

• Collaborate closely with IT and engage members from the business to implement system improvements and updates of safety database.

• Provide expert guidance on policies and procedures related to quality and compliance of expedited and periodic reports.

• Interpret FDA and EU regulations and ICH guidelines to ensure compliance globally.

• Ensure company polices and legal guidelines are followed at all times.

• Develop and support processes that facilitate achievement of GCS&PV objectives.

• Support any other project or perform any other task deemed appropriate by management.

Education:

• Bachelor's degree or master's degree in health care/pharmaceutical related field or project management

Required:

• Candidate is required to have five years of safety experience or related areas such as Clinical Risk Management, Clinical or Regulatory

Preferred:

• Strong knowledge base of pharmacovigilance regulations and can function with a high degree of autonomy

• Ability to engage cross-functional stakeholders both internal and external to our company

• Ability to identify potential compliance gaps and quickly develop solutions

• Detail-oriented individual who enjoys analyzing and comprehending complex documents, along with possessing proficient writing skills.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If …