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Regulatory Affairs, Pharmacovigilance and Quality Assurance Specialist,

3 miesięcy temu

Warszawa, Mazovia, Polska MSD Pełny etat

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 the field of pharmacovigilance is supporting all pharmacovigilance (PV) activities for our company AH products. This includes management of the day-to-day adverse events as well as the development/update/implementation/training on standard operational procedures (SOP).

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

Job Description and Responsibilities

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, MMD on local 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.
  • Manages packing material requests, development and approval.
  • Assisting in organization and overseeing field trials for new products.

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.
  • Assisting in organization and overseeing field trials for new indications.

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.
  • Keep files and archives related to Regulatory Affairs complete and updated.
  • Establishes and updates the relevant Standard Operating Procedures (SOP) to secure the current internal and external requirements on Regulatory Affair of the organization are compliant and implemented in requested time-lines.
  • Provides regulatory representation and support for internal and external audits related to regulatory affairs field.

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.
  • Takes part in BU products and launch teams to provide regulatory input and strategy advice is such is requested.
  • Support such the decisions they provide the best return on their commercial implications and is aware about the cost created by Regulatory Affairs.

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.
  • Participates in internal RA managers' meetings and contributes to our company AH workgroups or projects if so required.
  • Acts as a contact point for quality issues for Local Regulatory bodies.
  • Provides translation of the product literature from and to English language if requested.

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 actual requirements.
  • 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-control activities.
  • 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).
  • Ensures 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 DPOC team if assigned despite the position is responsible for independently carrying out these and other tasks.
  • Review marketing and sales promotional material on scientific content to ensure scientific accuracy and compliance with local regulations

Compliance

  • Ensures that all activities are in line with compliance and our company's code of conduct
  • Qualifications

Education: Veterinary Medicine (graduated Veterinarian)

Skills Required:

  • Polish nationality with proficient Polish language due to daily work with Polish language materials
  • 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
  • High level of diplomacy
  • Meticulous
  • Excellent planning and organization skills
  • Open for changes
  • Competent use of MS Office
  • Flexibility in working hours i.e. being available for emergencies by either mobile phone, office or home telephone, email or fax outside of office hours.
  • Competencies

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Temporary (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/6/2024

*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.

Job Posting End Date:08/06/2024

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.

Requisition ID:R304929