Sr PV Specialist

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Job Details

Pharmalex is recruiting for a talented Sr PV Specialist to join our team in the DACH region! We are looking for a fluent German speaker with 1-2 years experience as a PV Specialist/Drug Safety Associate who will be dedicated to our world-class pharmaceutical partner's project. This is a remote-based position that can be hired in Austria or Germany.

• Set up and manage the local pharmacovigilance system
• Local Literature Search
• Local ICSR Management
• PV Intelligence Screening
• Setting up local Organized Data Collection
• Local PVA Management
• Local adaptation and submission of PSUR / RMP
• 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
• Review protocols for local studies and define PV related processes for local study projects prior to their initiation, in order to ensure compliance with the pharmacovigilance requirements and company standards
  
  

Experience And Educational Requirements

• Minimum college level education required. A diploma or degree with a concentration in Life Sciences is a strong asset;
• 1-2 years experience in Medical Information, Clinical Research or Drug Safety or equivalent and related experience in pharmacy or pharmaceutical fields;
• Knowledge of Pharmacovigilance industry including up to date knowledge of; pharmacovigilance guidelines of Health Canada, US FDA, EMEA and ICH;
• Adaptability to change and to learn new skills as required;
• Experience in the medical and/or pharmaceutical field(s), medical terminology is an asset;
• Fluency in English and German
  
  

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: Alliance Healthcare Management Services Limited

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