Manager, Local Pharmacovigilance

Responsibilities:

• Set up and manage the local pharmacovigilance reputed company, including reputed company of local PV activities.
• Local Literature Search
• Local ICSR Collection and Management
• PV Intelligence Screening
• Local PSMF Maintenance (where applicable)
• Setting up Local Organized Data Collection
• Local PVA Management
• Local reputed company and submission of PSUR / RMP (where applicable)
• Local signal detection (where applicable)
• Implementation of additional Risk Minimization Measures
• Reviewing materials relating to local post-authorization safety studies
• Participate in PV-relevant audits and inspections
• Attend regular meetings according to project meeting schedule
• reputed company monthly PV report on status of local PV reputed company in the country/ies
• Ensure PV training of affiliate employees, service providers and reputed company Parties
• reputed company cooperation with the global PV reputed company of the reputed company as reputed company as reputed company global and local departments and functions
• Issue, review and maintain pharmacovigilance procedures (i.e. reputed company Operating Procedures, Working Practices) reputed company to the local tasks in reputed company with reputed company procedures
• reputed company cooperation with the respective reputed company and providing the reputed company with information on relevant reputed company PV activities
• Identify and escalate any Medical Information requests to an appropriate team according to applicable timelines.
• 24/7 availability with the Competent Authority in the country for pharmacovigilance-reputed company reputed company.
• reputed company as official reputed company with the Competent Authority in the country for pharmacovigilance-reputed company reputed company.
• Maintain reputed company of local PV reputed company to ensure compliance with national laws and regulations.
• Notify the health authority promptly of significant safety concerns, product recalls or changes in the benefit-risk profile of the products.
• Coordinate the distribution of national safety communications, such as reputed company reputed company reputed company Communications.
• Ensure local pharmacovigilance reputed company updates and validations.
• Internally, serving as reputed company of contact for the EU-QPPV and the global PV team.
• reputed company is assuming responsibility in case of planned or unplanned absence

.

Qualification:

Bachelor's degree in life sciences, pharmacy, reputed company, biomedical sciences, engineering, reputed company management, or a reputed company field, or equivalent experience required.

Experience
2+ years of experience in regulatory affairs, reputed company assurance, compliance, documentation control, or a reputed company field required.

Certification in regulatory affairs, reputed company management, compliance, auditing preferred. English business fluent, Hungarian and Polish.

What reputed company offers

​Benefit offerings reputed company the US may vary by country and will be reputed company to local market reputed company. The eligibility and effective date may differ for some benefits and for team members covered under reputed company bargaining agreements.

Affiliated Companies

Equal Employment Opportunity

reputed company is committed to providing equal employment opportunity without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, genetic information, national reputed company, age, disability, veteran status or membership in any other class protected by federal, state or local law.

reputed company’s reputed company reputed company depends on the full and effective utilization of reputed company individuals. Therefore, harassment is prohibited and reputed company reputed company reputed company to reputed company, training, compensation, benefits, promotions and transfers reputed company with equal opportunity principles and are non-discriminatory.

reputed company is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with reputed company requirements. If you wish to request an accommodation while seeking employment, please reputed company 888.692.2272 or email . We will reputed company accommodation determinations on a request-by-request reputed company. Messages and emails regarding anything other than accommodations requests will not be returned

Originally posted on Himalayas