Pharmacovigilance Specialist in Animal Health

Data: 2019-03-08

Location: Warsaw, PL

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Requisition ID: DRU000942

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


  


MSD is home to a diverse team of scientists and researchers who are working to push the boundaries of global healthcare through research and innovation. Relentlessly curious and driven, the Pharmacovigilance team produces effective, reliable medicine through clinical trials and surveillance that uncovers new knowledge, product discovery, and leading-edge medical breakthroughs.


 


 


 

Position Overview

 


 

The position shall be responsible for the pharmacovigilance (PV) system for veterinary medicinal products (VMPs) and the internal standard operational processes (SOP) in this area as well as for SOP development, update, trainings and process implementation in accordance to company standards and European Union (EU) and Polish legislation.


 


 


The position may be accountable for the deputyship in area of Regulatory Affair .


  


It requires as such keep an up-to-dated competence and awareness in the legal and procedural requirements as set up for Marketing Authorization Holder.


  


Major Activities                


Roles and responsibilities:




  •  DPOC is responsible for overall pharmacovigilance for all VMPs for which MSD Animal Health holds Marketing Authorizations in Poland and for products used in field trials (before and after obtaining authorization) in accordance to UE and Polish regulations and in accordance to actual standards described in internal company documents (as for example Corporate Policies, Standard operating Procedures, Work Instructions, User Manuals, Local Procedures etc.).

 




  • Maintenance of a PV system which ensures that information about all adverse events (AEs) that are reported to any personnel of MSD Animal Health, including its representatives, temporary staff and contract employees, is collected and collated in order to be accessible in at least one point within the EEA.

 




  • Overseeing of the pharmacovigilance data quality and information collection process (including logistic process related to samples accompanying pharmacovigilance report).

 




  • Entering reports to the company pharmacovigilance database (translated to English language) and processing related data and documents in accordance to actual requirements.

 




  • Development/adaptation of any applicable local procedures including training of personnel, documentation of the training process and process implementation.

 




  • Assurance of the implementation of appropriate Pharmacovigilance related vocabulary in applicable contractual agreements (including field trials related documentation).

 




  • Participation in audits and controls of the PV system performed by competent authorities as well as involvement in post-audit and post-control activities.

 




  • The submission of PV reports (periodic safety update reports (PSURs) for the national competent authorities (NCAs) if so is requested


  • The conduct of continuous overall PV evaluation during the post-authorization period

     


    Ensuring that any request from the national competent authorities (NCAs) for the provision of additional information necessary for the evaluation of the benefits and risks of a VMP is answered fully and promptly, including the provision of information about the volumes of sales or prescription of the VMP concerned (in accordance to corresponding procedures).

 




  • Provision to the NCAs of any other information relevant to the evaluation of the benefits and risks of a VMP, including appropriate information on post-authorization studies (in accordance to corresponding procedures).

 




  • If nature of the tasks requires in all this areas of responsibility the position keeps close coordination and communication with Country Manager, Global Qualified Person responsible for Pharmacovigilance (QPPV) or Global PV team, Regulatory Manager of any other member of local team if assigned despite the position is responsible for independently carrying out these and other tasks.

 




  • The position is embedded in MSD Animal Health’s organization and therefore being subordinate in specific lines (functional and/or hierarchical).


 

Qualifications

Expertise Required / Core Competences  


 




  •  Regulatory notification: The name and address details of the position are presented to Polish competent authorities (registration Office Chairman should receive copy of diploma and CV).



  • Accessibility: The position must ensure that his/her contact details are sent to the appropriate person(s) or department(s) (e.g. local and global RA) to be added to the local and global emergency contact lists, and to ensure that the emergency contact lists contain up-to-date information. The position of its deputy has to maintain availability either by mobile phone, office or home telephone, email or fax, within office hours.



  • Professional Competence:




    • English in excellent written and verbal command




    • Preferred diploma in veterinary medicine (possible as well zootechnician, master of pharmacy or diploma in the field of the medical or biological sciences but in such case, if person has no veterinary medicine diploma company has to assure constant access of the person to graduated veterinarian)




    • Professional experience guarantying reliable performance of the obligations related to continuous monitoring of the veterinary medicinal products safety




    • Satisfactory time and content of practice in regulatory affair or pharmacovigilance area




    • High competence to work in MS-Office (Word, Excel, Power Point, Outlook) and in IT technology in general




    • Expertise in Social Media




    • High degree of motivation and work engagement



  • High level of presentation abilities, communications and team-cooperation

 


 


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.



Job: Drug/Dvcs Sfty Survnce (NonMD)
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD

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