What are the responsibilities and job description for the Pharmacovigilance Reporting Specialist position at Virbac?
Experiencing together a unique human adventure
Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.
To ensure Virbac maintains good pharmacovigilance standards by executing and submitting adverse event reports to required Regulatory and Intracompany Authorities.
Area of responsibility 1 :
Reporting to relevant Regulatory and Intracompany Authorities
Main Activities :
- Compile data from the rest of the Pharmacovigilance Consulting and Reporting team and complete reports for the relevant Regulatory and Intracompany Authority within the appropriate timeframes.
- Assist with VeDDRA and ABON coding of adverse event, lack of efficacy and product quality complaint cases.
- Reports to Regulatory Authorities including but not limited to FDA, EPA, VDD, PMRA, NASC, Virbac SA.
Expected results :
Provide an accurate report to the appropriate Regulatory and Intracompany Authority within the required timeframe for each product and case type.
Area of responsibility 2 :
Conduct all operations within the applicable Standard Operating Procedures and Work Instructions for the Department
Main activities :
Expected results :
Helps department remain in compliance with all company SOPs and contributes toward overall compliance with all relevant regulations.
Area of responsibility 3 :
Assist in ensuring regulatory compliance of marketed products
Main activities
Expected results :
Provides timely and accurate reports to the appropriate Regulatory and / or Intracompany Authorities or Third Parties to remain in compliance with regulations.
Area of responsibility 4 :
Assist in maintaining a current and validated pharmacovigilance database system
Main activities :
Expected results :
Assists in maintaining a validated and current pharmacovigilance database system.
Area of accountability no.5 :
Receive and document events into pharmacovigilance database as required or requested
Main activities :
Expected results :
Contributes to maintaining an accurate database to support good pharmacovigilance standards in compliance with all relevant Regulatory Authorities and Company standards.
Requirements (Diploma and experience)
Bachelor degree or equivalent required. Higher level degree from an accredited institution in life sciences, pharmacy, or related field strongly preferred.
Minimum of five (5) years of experience in veterinary / medical field, drug safety / pharmacovigilance, pharmaceutical industry, CRO, or regulatory field.
Working experience and strong understanding of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA) strongly preferred.
Skills
Virbac provides numerous career opportunities, thanks to the diversity of its jobs and their international dimension.
Joining Virbac means joining dynamic teams ambitious for success.
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