MSD Local Regulatory Affairs Pharmacovigilance Quality Assurance Specialist 

Czechia 

446757453

Job Description

The Local Regulatory Affairs, Pharmacovigilance and Quality Assurance Specialist provides support, control and communication around veterinary medicinal products marketing authorizations (MA) and is responsible for Regulatory Affairs, Pharmacovigilance, Clinical Trials and Quality Assurance topics and processes, acts in a business-oriented way in terms of Regulatory Affairs during product development, as well as to get the best-authorized profile in order to introduce the product in the market in the shortest period.

In addition, supports SOP on market support studies as well as the approval process of marketing and sales activities.

Current Contingent Workers apply

New Marketing authorizations

• Ensures timely and correct submission and approval of new MA applications in close cooperation with relevant persons namely Local Regulatory Affairs Specialist/Manager and in global regulatory affairs, management, marketing, external affairs departments, research, or global level.
• Tracks process and manages answers to requirements from the Agency on products registration and major new indications, involving negotiations to achieve the best commercial outcome.
• Actively supports translation of product literature to local language.

Maintenance of Marketing Authorization (MA)

• Ensures that MA are maintained through control of due time frames and a timely implementation of necessary activities including variations (and renewals, if required).
• Communicate actions and evolution to stakeholders using described process if such exists.
• Manages packing material updates requests, development and approval.

Compliance and Artwork

• Supports maintenance and update of the databank of valid versions of Summary of Product Characteristics (SPC), packaging materials and other applicable regulatory documents according to our company and local standards.
• In coordination with Local Regulatory Affairs Specialist/Manager inform internal stakeholders and colleagues on all relevant information with regard to the regulatory status of the products namely on update of SPC, via a regular RA communication on update on the status of main activities and main RA topics to share.
• Stay in contact with MMD to ensure that updated artworks of product packaging are produced and used within legal timeframes namely by appropriate use software to generate artwork and to implement revisions of the artwork in due time.
• Guarantees consistent use of internal and external regulatory databases and systems in the country in such a way the data provided are the most up-to-dated.

Cross-functional activities

• Ensures adequate support to other functions to enable compliance in areas related to regulatory, such as review of promotional material, customer presentations incl. social media.
• Gives strategic regulatory advice or feedback to maximize best positioning of products and company business.
• Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners if relevant.
• Good Distribution Practice

• May be required to act as Qualified Person/Responsible Person for Veterinary Wholesale (in area of the Good Distribution Practice) or directly support/cooperate with this role

Regulatory Affairs environment

• Keeps abreast of local (in the country of operation) and UE and international laws and tendencies in order to identify and track on topics they might influence our company interests.
• Through active participation in the regulatory work of the local Pharmaceutical industry Association and task forces with the Agency, the incumbent seeks alignment of industry position with our company interests if required.
• Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders, and in concurrence with our company Regulatory Affairs positions.

Pharmacovigilance

• Maintains PV system, which ensures that information about all adverse events (AEs) that are reported to any personnel of our company 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.
• Oversees of the pharmacovigilance data quality and information collection process.
• Enters reports to pharmacovigilance database (translated to English language) and processing related data and documents in accordance to actualrequirements.
• Develops and adapts applicable local procedures including training of personnel, documentation of the training process and process implementation.
• Assures the implementation of appropriate Pharmacovigilance related vocabulary in applicable contractual agreements (including field trials related documentation).
• Participates in audits and controls of the PV system performed by competent authorities as well as involvement in post-audit and post-controlactivities.
• Conducts continuous overall PV evaluation during the post-authorization period.
• Ensures 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).
• Provides 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).

: Veterinary Medicine (graduated Veterinarian)

Skills Required:

• Local country language - native speaker
• Excellent in English, written and verbal, skill is needed to prepare translation of the English texts to national language
• Preferred at least 1-year experience in regulatory affairs
• Preferred experience in pharmacovigilance
• Preferred experience in Good Distribution Practice and Quality Assurance
• Familiar with local and EU legislation procedures at the level of regulatory affairs
• Excellent communication skills
• Excellent teamwork

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.