Senior Specialist, Pharmacovigilance

​Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.

The Senior Pharmacovigilance Specialist is responsible for the execution of tasks and all aspects of technical delivery in the field of Local Pharmacovigilance.

Responsibilities:

• Data entry and quality control of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; reporting of ICSRs to the competent authorities
• Support in the generation, processing, documenting, and tracking of follow-up requests
• Screening and documentation of scientific literature regarding safety relevant publications
• Assist in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), risk management plans and signal detection reports
• Interact with customers as needed (e.g. meetings, client visits, day to day case processing, etc.)
• PSMF maintenance
• Contribute to/review QA documents such as Working Instructions, SOPs, Working Procedures, templates, project metafiles, etc. for pharmacovigilance projects
• Prepare for and participate in internal and external audits/inspections
• Training new colleagues in relevant tasks
• The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required.

National Contact Person (NCP)):

• Act as official liaison with the Competent Authority in the country for pharmacovigilance-related matters.
• Maintain oversight of local PV system 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 Direct Healthcare Professional Communications.
• Ensure local pharmacovigilance system updates and validations.
• Internally, serving as point of contact for the EU-QPPV and the global PV team.
• The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required.

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Experience:

• Professional education or University degree in Life Science preferred but not essential

• Basic understanding/knowledge in the field of pharmacovigilance and medical information.

Skills:

• Ability to prioritize and manage own time and tasks.

• 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 point out issues and provide potential options for solution in the area of expertise.

• English business fluent.

What Cencora offers

​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

Affiliated Companies

Affiliated Companies: PharmaLex Portugal Unipessoal Lda (= Pharsolution Lda)

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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned