Specialist Local Pharmacovigilance and Medical information

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 Local Pharmacovigilance Specialist 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

Medical Information

• Address Medical Information requests (MIR) from multiple programs and sources using approved response documents.
• Ensure that all the MIR are processed and documented according to PLx and client procedures, and project working practice.
• Identify and document adverse events (AE), product complaints, and quality issues according to PLx and clients’ procedures.
• Report AE information to the pharmacovigilance department.
• Collaborate with PLx and client's internal teams, including regulatory, medical affairs and marketing to provide scientific support as needed.
• Participate in client's product training, diseases and therapeutic areas, as per project requirement.
• Support project team on any report clarification, metrics, volumes, KPIs and compliance investigations.
• Escalate L2 MIR as per project agreement.
• Support in internal and external audits. 
• Perform quality control of MIR to ensure adherence to project requirements and procedures.
• Reconcile medical information reports with adverse events and product quality complaint reports within the agreed timelines.

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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.

Experience:

• Professional education or University degree in Life Science.
• Basic understanding/knowledge in the field of pharmacovigilance and medical information.

Skills:

• Fluency in Finnish
• 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.

Affiliated Companies

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