Pharmacovigilance Manager (PV), (based in Latvia)

Position Type: Full time

Main purpose of Job:

The PV manager is responsible for leading safety risk management activities including; signal evaluation and management, update and maintenance of core safety documents, aggregate report production and general PV support to clinical development and post-marketing surveillance.

Duties & Responsibilities:

• Perform Medical review of ICSRs;
• Compile data and review of safety data for signal detection/management activities;
• Oversee the maintenance and production of aggregate safety reports;
• Provide PV input into other regulatory documents or dossiers as required;
• Support the safety evaluation team to ensure all activities are carried out and recorded appropriately;
• Provide mentoring and training to newer PV team members, when required;
• Lead ongoing scheduled and ad-hoc safety signal detection activities as required;
• Manage detected signals through the evaluation process;
• Evaluate safety data for presentation at the Corporate Safety Board;
• Create and maintain aggregate safety reports;
• Other medical writing or risk management activities;
• Respond to safety related queries from internal and external partners including Regulators;
• Execute additional tasks in order to meet departmental project-related or developmental / change objectives.

Skills:

• Ability to lead the evaluation and resolution of safety issues with cross-functional teams;
• Requires good operating knowledge, retrieval of data, from pharmacovigilance databases;
• Proficiency with safety databases and safety coding dictionaries (e.g., MedDRA, WHODRUG);
• Detail-oriented, with good organizational, prioritization, communication, and time management proficiencies;
• Strong leadership and people management experience;
• Excellent communication and collaboration skills with the ability to present to internal/external groups and establish and maintain good working relationships at all levels.

Qualifications and Experience:

• Minimum Life Science Degree;
• Demonstrable experience in safety evaluation and risk management in the clinical development and/or post-marketing setting gained in pharmaceutical industry in the previous 5 to 7 years;
• Excellent communication and IT skills.

Goals for 2019:

Project by project list of the activity foreseen into the contract and KPI accordingly.

What we offer:

• Modern working conditions in the heart of Riga city center;
• Challenging work with a young and motivated team of professionals;
• Competitive salary;
• Fast-growing organisation with international experience in pharmaceutical GxP Consulting and IT Solutions;
• A dynamic and inspiring working environment.

Please send your CV and application letter (in English) to e-mail info@inpharmatis.com.

If you would like to work in a great team with the latest technologies on really challenging international projects, we look forward to seeing your resume.

N.B. We will contact only those candidates who will be invited for the interview!

Purpose of personal data processing: a selection of the candidate and completion of the specific selection process.

REGULATORY AFFAIRS SPECIALIST (RA), (based in Lithuania and Estonia)

• Position Type: Full time
• Duties & Responsibilities:
  • Pre-lodgement assessment of documents for new applications with respective regulatory authorities;
  • Advising on the best type and location of applications lodgement;
  • Advising on legal requirements of documentation;
  • Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is working with, in particular EU;
  • Requesting, collecting, collating and evaluating scientific data provided for lodgement with respective regulatory authorities;
  • Developing and writing clear arguments and explanations for new product registrations and registration renewals;
  • Preparing submissions of registration variations and renewals to strict deadlines;
  • Monitoring and setting timelines for registration variations and renewal approvals;
  • Working with specialist computer software and resources (e.g. eCTD software, Eudravigilance, etc.);
  • Writing clear, accessible product labels, patient information leaflets and summary of product characteristics in accordance with quality and clinical documentation and regulations in effect;
  • Organizing, executing and preparing specific reports;
  • Planning and developing product trials and interpreting trial data (after training);
  • Advising Clients on scientific and manufacturing regulatory requirements;
  • Providing strategic advice to senior management on regulatory requirements and changes;
  • Reviewing practices and providing advice on changes to systems (SOPs);
  • Negotiating with regulatory authorities for marketing authorizations;
  • Preparing proposals, developing reports and documentation, reporting within electronic systems, monitoring and lodging all necessary reports for PharmacoVigilance (acting as deputy QPPV, after training);
  • Working in collaboration with other colleagues in Clinical, Quality, Auditing, and Regulatory Affairs Departments in order to achieve successful registrations and maintenance of registrations of the product.

  Skills:

  • Shorthand and excellent typing skills;
  • Good computer literacy, speed, and accuracy essential (MS Office);
  • Excellent verbal and written Latvian, English and Russian;
  • Excellent organizational skills;
  • Attention to detail;
  • Professional telephone manner;
  • Proven ability to work under pressure and to tight deadlines;
  • Bright, confident personality;
  • Well presentation skills;
  • Flexible and mature approach with the ability to work unsupervised.

  Qualifications and Experience:

  • Minimum of BPharm, MPharm preferred (BS, MD acceptable);
  • Experience of working within an international environment (international organization);
  • Experience of dealing with different time zones.

  What we offer:

  • Challenging work with a young and motivated team of professionals;
  • Competitive salary;
  • The fast-growing organization with international experience in pharmaceutical GxP Consulting and IT Solutions;
  • A dynamic and inspiring working environment.

   

  Please send your CV and application letter (in English) to e-mail info@inpharmatis.com.

  If you would like to work in a great team with the latest technologies on really challenging international projects, we look forward to seeing your resume.

  N.B. We will contact only those candidates who will be invited for the interview!

  Purpose of personal data processing: a selection of the candidate and completion of the specific selection process

   

  For more details or initial consultation, please contact Inpharmatis Team: info@inpharmatis.com