Regulatory affairs/pharmacovigilance project manager

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.
• 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 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 EU for ensuring local pharmacovigilance activities for the client.
• Coordinate with QPPV and PV team for relevant safety/PV requests from 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 team and experts to ensure smooth project flow.
• Use 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.