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Job Details

Maintain oversight of local PV system to ensure compliance with national laws and regulations.

Local Literature Search

Local ICSR Management

PV Intelligence Screening

Local PSMF Maintenance

Setting up local Organized Data Collection

Local PVA Management

Implementation of additional Risk Minimization Measures

Reviewing materials relating to local post-authorization safety

Participate in PV-relevant audits and inspections

Attend regular meetings according to project meeting schedule

Provide monthly PV report on status of local PV system in the country/ies

Ensure PV training of affiliate employees, service providers and Third Parties

Close cooperation with the global PV system of the client as well as related global and local departments and functions

Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures

Experience and Educational Requirements

 

• University degree in Life Science
• At least 3 years’ experience in the field of pharmacovigilance  
• Expertise, experience and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance

 

Minimum Skills, Knowledge and Ability Requirements

• Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope.
• Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level.
• Good communication skills (written and verbally); capability to communicate issues and propose solutions.
• English business fluent
• Spanish business fluent (nice to have)

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

3+ years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field required.

Certification in regulatory affairs, quality management, compliance, auditing preferred.

What Cencora offers

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

Full time

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Affiliated Companies

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Affiliated Companies: PharmaLex Spain S.L.U.

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Equal Employment Opportunity

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

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

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