Manager Local Pharmacovigilance

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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.

The Manager of Local Pharmacovigilance is responsible for the execution of operational tasks and all aspects of technical delivery and project management in the field of Local Pharmacovigilance.

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

Experience

• Several years' experience and profound knowledge in the field of pharmacovigilance
• Expertise, experience and knowledge regarding relevant legislative and non legislative guidelines on pharmacovigilance

Skills

• Leadership: Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads).
• Task and project management skills: Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope.
• (Customer) Relationship skills: Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level.
• Communication & presentation skills: Good communication skills (written and verbally); capability to communicate issues and propose appropriate solutions to decision makers.
• Good presentation skills.

**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 Bulgaria, Jsc

*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 or email We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned