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Pharmacovigilance Specialist

priority vacature priority vacature


Temporary position for an interesting pharmacovigilance project for three to six months.

Het bedrijf / The company

Our client has been a leading provider of risk management and compliance services to the Life Sciences industry since 2008. These include market consultancy, global regulatory affairs strategy and implementation, full and local pharmacovigilance solutions, clinical drug safety, and quality and compliance auditing and systems. They want to make the process from development to market faster, better and smarter. The headquarter of this organization is located in Ireland, with European operations in Central Europe. They are currently operating in 148 countries with the desire to expand. In the position as Pharmacovigilance Specialist in this organisation you directly report to the Team Lead of the unit. The team is based in Prague but as PV Specialist you can work remotely.

De functie / The role

As a Pharmacovigilance Specialist you will work on projects and tasks assigned by the unit Team Lead. You will ensure the delivery of projects/tasks is in accordance with the clients’ needs as per the contractual agreements and procedures. Furthermore, you will follow and achieve KPIs of the department. You will constantly seek for the clients’ and internal feedback and take this into consideration to improve the efficiency and quality of the work within the assigned projects. Therefore, you will effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication, ensuring full compliance with the processes and project deliverables. You have to oversee the work performed by the project team members (PV associates, PV assistants) and ensure a high standard and quality of delivered work.
Furthermore, you will ensure that all CAPAs related to assigned projects and tasks are managed, while keeping an eye on the deadlines. You will participate in audits and inspections. You must organise and file the documents according to the company’s document management system and therefore use the company’s databases, systems and any other IT tools.
You will provide trainings to the project team members and other PV department employees on technical areas where needed. You will also participate in trainings yourself, both internal and external. You are going to improve the teamwork collaborations by sharing the best methods.

Het profiel / Your profile

• Bachelor’s degree or graduate in Pharmaceutical Sciences or related fields; advanced degree (e.g. Masters) preferable
• at least one year of experience working in a medical or safety department with demonstrable expertise of medical terminology
• detailed knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.)
• experience with a safety database is desirable
• ability to delegate and oversee work of staff and an excellent team player
• organizational and time-management skills, able to prioritize work and adhere to deadlines
• maintaining a positive, result-oriented work environment
• excellent communication skills in English, both verbal and written, additional languages are preferable but not a must

Het aanbod / The offer

• diverse job at a pharmacovigilance department
• working in a highly qualified and driven team
• interesting job because of the international contacts
• temporary contract at Derks & Derks for 3 to 6 months

Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-040-DD, to Minke Gastreich: info@derksenderks.nl.

For further information, please call Minke Gastreich at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.


Derks & Derks Detachering
Derks & Derks

Geplaatst op FMF: 19 februari 2021

Branche: Farma & Biotech
Functie: QA / regulatory, Clinical research
Opleidingsniveau: HBO / BSc, WO/academisch / MSc
Werkervaring: 0-2 jaar, 2-5 jaar, 5-10 jaar