Responsibilities:

As QPPV:

• Provide expert leadership and guidance in pharmacovigilance and QPPV services.
• Lead and oversee GVP-compliant Pharmacovigilance Systems and related PV documentation.
• Advise clients, internal teams and regulatory authorities on PV matters.
• Ensure quality, compliance and continuous improvement, including oversight of deviations and CAPAs.
• Support audits, inspections, project delivery and business development.
• Identify and proactively address risks, quality issues and process inefficiencies.
• Build strong client relationships and ensure high-quality service delivery.
• Mentor and develop new QPPVs and deputy QPPVs.

 

As GPO:

• Responsible for the establishment, maintenance and oversight of the local pharmacovigilance system in Germany in accordance with §63a AMG and §19 AMWHV.
• Act as the official pharmacovigilance contact for the competent German authorities.
• Collect and evaluate medicinal product risks in Germany, including quality-related safety issues, and coordinate appropriate risk-minimisation measures.
• Notify and escalate safety-critical issues to the competent German authorities, including deficiencies potentially leading to recalls or restrictions of distribution and suspected falsified medicinal products.
• Coordinate German safety communications, including Direct Healthcare Professional Communications (DHPCs).
• Ensure continued compliance of local German PV processes and procedures with applicable national regulatory requirements.
• Closely collaborate with the MAH, EU-QPPV and relevant global PV functions on Germany-specific safety and compliance matters.

.

Qualification:

Bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required.

Experience:
Min 5 years QPPV experience and 2 years GPO experience + fluency in German language (business level for interaction with authorities) are a must.

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 GmbH

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 [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