Regulatory Affairs/Pharmacovigilance Project Manager

ELC Group

Industry: Medical, Health, Fitness, Beauty

City: Yerevan

Employment type: Full time

Deadline: 11/8/2020

Excellent opportunity for fresh graduates!

By joining our international team you will work closely with colleagues from different countries and departments and you will be a key contact person for our clients for new products and compliance-related issues. You will be able to work from home as a contractor, with a regular 8 hours a day schedule.

To be successful in this role you need to:

  • Be proficient in written and spoken English; knowledge of other languages is a distinctive advantage.
  • Understand project management.
  • Knowledge of Product Life Cycle Management and EU regulations and guidelines is an advantage Experience of eCTD would also be beneficial.
  • A University degree or equivalent experience in Life Sciences (Chemistry, Pharmacology, Biology, Medicine, etc.) is an advantage.
  • Be flexible and adaptable to changing project priorities and work assignments
  • Be able to work under strict timelines
  • Have excellent communication skills

You will be required to:

General Project Management

  • Design and implement project plans by coordinating with other departments as well as with clients to ensure that projects are implemented, deadlines are met and deliverables are of high quality.
  • Identify and report project and deliverable related risks to direct managers or relevant experts.
  • Follow current Standard Operating Procedures (SOP) guidelines regarding procedural steps throughout the entire life cycle of the project.
  • Act as (Single) Point of Contact and oversee clients' portfolios. 

Regulatory Affairs

  • Submit registration and maintenance documents to regulatory agencies and carry out all the subsequent negotiations and activities necessary to obtain and maintain the marketing authorization for the products.
  • Work closely with government agencies to ensure all legislation is closely followed and the clients' products comply with the regulations. 

Pharmacovigilance

  • Function as an interface for clients regarding project management activities including deliverables as per service agreement and technical agreement.
  • Liaise and coordinate with local responsible PV personnel/ local PV representatives in the EU for ensuring local pharmacovigilance activities for the client.
  • Coordinate with QPPV and PV team for relevant safety/PV requests from the client.
  • Coordinate with the client for specific data for PSURs, PSMF, and RMP and other reports.
  • Ensure that local literature search and monitoring of local health authorities’ website is performed.
  • Assist in invoicing and billing related queries with finance and admin team.
  • Prepare monthly PV activity reports, review, and communicate with different clients regarding ongoing quality and compliance PV activities.
  • Attend regular teleconferences with clients, technical teams, and experts to ensure smooth project flow.
  • Use a project management database for clear project status and closure. 

ELC GROUP is a fully-fledged global regulatory partner, working with major pharmaceutical stakeholders for over a decade. The company is based in Prague with offices in Romania and India. We are now facing an exciting time with further expansion of the business, leading to a number of opportunities arising to join the ELC GROUP team. 

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