Offer summary

Qualifications:

University degree in Life Science is desirable but not essential., Several years’ experience and profound knowledge in pharmacovigilance., Expertise in relevant legislative and non-legislative guidelines on pharmacovigilance., Ability to lead, mentor, and manage staff, and to communicate effectively in English and Italian..

Key responsibilities:

Set up and manage the local pharmacovigilance system.

Conduct local literature searches and manage Individual Case Safety Reports (ICSRs).

Participate in PV-relevant audits and inspections, and provide regular PV reports.

Job description

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

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.

We are looking for a talented Pharmacovigilance Manager to join our team in Italy.

Responsibilities:

Set up and manage the local pharmacovigilance system
Local Literature Search
Local ICSR Management
PV Intelligence Screening
Local PSMF Maintenance
Setting up local Organized Data Collection
Local PVA Management
Local adaptation and submission of PSUR / RMP
Local signal detection
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
Close cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activities
Deputy is assuming responsibility in case of planned or unplanned absence
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

Education:

University degree in Life Science is desirable but not essential
Several years’ experience and profound knowledge in the field of pharmacovigilance
Expertise, experience and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance

Work Experience:

Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads).
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 appropriate solutions to decision makers. Good presentation skills.
English business fluent & Italian.

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 Italy SPA

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

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