Manager, Local Pharmacovigilance

📋 Description

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

• Conduct local literature searches.

• Collect and manage local Individual Case Safety Reports (ICSR).

• Perform PV intelligence screening.

• Maintain the local Pharmacovigilance System Master File (PSMF).

• Organize local data collection processes.

• Manage local Pharmacovigilance Activities (PVA).

• Adapt and submit local Periodic Safety Update Reports (PSUR) and Risk Management Plans (RMP).

• Execute local signal detection activities.

• Implement additional Risk Minimization Measures as needed.

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

• Engage in audits and inspections relevant to pharmacovigilance.

• Participate in regular meetings as per the project meeting schedule.

• Provide a monthly report on the status of the local pharmacovigilance system in the respective country or countries.

• Ensure that affiliate employees, service providers, and third parties receive appropriate pharmacovigilance training.

• Collaborate closely with the client's global pharmacovigilance system as well as related global and local departments and functions.

• Issue, review, and maintain pharmacovigilance procedures (including Standard Operating Procedures and Working Practices) pertinent to local tasks in conjunction with client protocols.

• Work closely with the Deputy, supplying them with information about relevant current pharmacovigilance activities.

• Identify and escalate any Medical Information requests to the appropriate team within the specified timelines.

• Be available 24/7 for the Competent Authority in the country regarding pharmacovigilance-related matters.

• Act as the official liaison with the Competent Authority in the country for all pharmacovigilance-related issues.

• Maintain oversight of the local pharmacovigilance system to ensure adherence to national laws and regulations.

• Promptly notify the health authority of significant safety concerns, product recalls, or changes in the benefit-risk profile of the products.

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

• Ensure that the local pharmacovigilance system is updated and validated regularly.

• Serve as the internal point of contact for the EU-QPPV and the global pharmacovigilance team.

• Ensure the Deputy assumes responsibility in case of any planned or unplanned absence.

⛳️ Requirements

• A university degree in Life Sciences.

• Extensive experience and in-depth knowledge in the field of pharmacovigilance.

• Expertise and familiarity with relevant legislative and non-legislative guidelines concerning pharmacovigilance.

• Proficiency in English at a business level.

🏝️ Benefits

• Benefits offered outside the US may differ by country and will align with local market practices. The eligibility and effective date may vary for certain benefits and for team members covered under collective bargaining agreements.