Manager, Local Pharmacovigilance

This is a fully remote position, open to applicants in Latvia.

📋 Description

• Establish and oversee the local pharmacovigilance system, including management of local PV activities.

• Execute local literature searches.

• Gather and manage local individual case safety reports (ICSRs).

• Conduct PV intelligence screening.

• Maintain the local pharmacovigilance system master file (PSMF), when applicable.

• Organize local data collection efforts.

• Oversee local pharmacovigilance agreements (PVAs).

• Modify and submit local PSURs/RMPs, when applicable.

• Carry out local signal detection, when applicable.

• Implement additional risk minimization strategies.

• Review materials pertaining to local post-authorization safety studies.

• Engage in PV-related audits and inspections.

• Participate in regular project meetings.

• Provide monthly updates on the status of the local PV system in the relevant country/countries.

• Ensure PV training for affiliate staff, service providers, and third parties.

• Collaborate with the client's global PV system and associated global and local departments and functions.

• Draft, review, and maintain pharmacovigilance procedures, including SOPs and operational practices.

• Work with the respective Deputy to share information about ongoing PV activities.

• Identify and escalate Medical Information requests within the required timelines.

• Inform the health authority about significant safety issues, product recalls, or changes in benefit-risk profiles.

• Coordinate the dissemination of national safety communications, including Direct Healthcare Professional Communications.

• Ensure updates and validations of the local PV system.

• Act as the internal point of contact for the EU-QPPV and global PV team.

• Take on Deputy responsibilities during planned or unplanned absences.

⛳️ Requirements

• Bachelor’s degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience is required.

• Minimum of 2 years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field is required.

• Certification in regulatory affairs, quality management, compliance, or auditing is preferred.

• Proficient in English, both written and spoken.

• Local language proficiency: Latvian, Estonian, and Lithuanian.

• Availability 24/7 for pharmacovigilance-related matters with the Competent Authority in the country.

• Ability to serve as the official liaison with the Competent Authority.

• Understanding of national laws and regulations relevant to pharmacovigilance.

🏝️ Benefits

• Benefit offerings outside the US may differ by country and will align with local market practices.

• Adherence to equal employment opportunity principles and non-discriminatory practices in recruiting, training, compensation, benefits, promotions, and transfers.

• Reasonable accommodations provided during the employment process for individuals with disabilities.