Cencora

Distributes medicines and supports patient care

Manager – Local Pharmacovigilance

Biology & BiotechConfirmed live in the last 24 hours

Full-timeNo salary listedIn-person

About the Job

Requirements

A bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience, is required.
At least 2 years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field is required.
Business-fluent English and the local language are required.

Responsibilities

Set up and manage the local pharmacovigilance system, including oversight of local pharmacovigilance activities.
Conduct local literature searches.
Collect and manage local individual case safety reports.
Screen pharmacovigilance intelligence.
Maintain the local product safety master file, where applicable.
Set up local organized data collection.
Manage local pharmacovigilance agreements.
Adapt and submit local periodic safety update reports and risk management plans, where applicable.
Conduct local signal detection, where applicable.
Implement additional risk minimization measures.
Review materials relating to local post-authorization safety studies.
Participate in pharmacovigilance-relevant audits and inspections.
Attend regular meetings according to the project meeting schedule.
Provide a monthly report on the status of the local pharmacovigilance system in the country or countries.
Ensure pharmacovigilance training for affiliate employees, service providers, and third parties.
Work closely with the client's global pharmacovigilance system and related global and local departments and functions.
Issue, review, and maintain pharmacovigilance procedures, including standard operating procedures and working practices, for local tasks in connection with client procedures.
Work closely with the respective deputy and provide the deputy with information on relevant current pharmacovigilance activities.
Identify and escalate medical information requests to the appropriate team according to applicable timelines.
Be available 24/7 to the competent authority in the country for pharmacovigilance-related matters.
Act as the official liaison with the competent authority in the country for pharmacovigilance-related matters.
Maintain oversight of the local pharmacovigilance system to ensure compliance with national laws and regulations.
Promptly notify the health authority of significant safety concerns, product recalls, or changes in the benefit-risk profile of products.
Coordinate distribution of national safety communications, such as Direct Healthcare Professional Communications.
Ensure local pharmacovigilance system updates and validations.
Serve internally as the point of contact for the EU Qualified Person Responsible for Pharmacovigilance and the global pharmacovigilance team.
Assume responsibility as deputy in the event of the primary role holder's planned or unplanned absence.

Desired Qualifications

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

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Responsibilities:

Set up and manage the local pharmacovigilance system, including oversight 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 adaptation 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
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
Close cooperation with the respective Deputy and providing the Deputy with information on relevant current 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-related matters.
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.
Deputy is assuming responsibility in case of planned or unplanned absence

Qualification & Experience required:

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

2+ 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.

English business fluent & local language

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 Spain S.L.U.

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

About the Company

Cencora

Distributes medicines and supports patient care

Cencora buys and distributes medicines for pharmacies, hospitals and physician practices, while helping drug manufacturers bring treatments to patients. Its businesses combine wholesale supply networks with specialty distribution for complex therapies and services that support prescribing and patient access. Customers order medicines through its distribution systems, and its teams manage sourcing, storage and delivery alongside pharmacy operations and manufacturer support. It earns revenue from pharmaceutical sales and fees for logistics and healthcare services. The parent company was formed in 2001 through the merger that created AmerisourceBergen, adopted the Cencora name in 2023, and is headquartered in Conshohocken, Pennsylvania.

Company size: 10,001+
Company stage: IPO
Headquarters: Conshohocken, PA
Founded: 2001

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