Director of Pharmacovigilance

Location: Full Remote

Contract: Freelance or flexible collaboration, with long-term potential

Concerning PMC:

PMC constitutes a patient-centric company, irrevocably committed to the rigorous development of innovative therapeutics and the unwavering assurance of patient safety.

Originating from a small team of four visionaries, PMC has now evolved into a leading company in Romania, with an expanding footprint across the EU and beyond.

Its narrative is one of consistent growth, fueled by an unwavering commitment to excellence and innovation.

Its fundamental mission remains steadfast: to deliver tailored, strategic solutions with competence, professionalism and respect.

Every project, every collaboration, every innovation reflects its relentless drive to establish new benchmarks within the pharmaceutical landscape.

Today, PMC stands as a name synonymous with trust and expertise, underpinned by a diverse team of Experts adept at managing complex EU and non-EU projects with precision and insight, strategic partnerships with both national and international organisations amplifying the reach and impact of its endeavors, academic collaborations that maintain its position at the forefront of R&D, advanced Clinical Trial Units ensuring cutting-edge contributions to Science and Medicine, and pioneering AI-driven projects that are actively shaping the future of Healthcare through Technology.

A Director of Pharmacovigilance of extensive experience and strategic acumen is hereby sought to assume leadership of global drug safety operations and to ensure the apotheosis of patient safety standards.

Positional Overview:

Director of Pharmacovigilance shall bear responsibility for the provision of strategic leadership and comprehensive oversight for all Pharmacovigilance activities undertaken within PMC. This encompasses the meticulous formulation, diligent implementation and proficient administration of Pharmacovigilance systems and processes designed to ensure rigorous adherence to global regulatory mandates and to continuously monitor the safety profile of PMC's client product portfolio.

Director of Pharmacovigilance will lead a specialised team of Pharmacovigilance Experts and will function as a pivotal liaison with Competent Authorities.

Principal Responsibilities:

· Coordinating the Pharmacovigilance services provided to clients (MAHs, distributors, licensees):

• ICSRs management, PSUR, RMP, signal management, PSMF, DSUR, safety database management;

• literature screening, drafting SOPs, updating safety sections CTD.

· Support clients in maintaining Pharmacovigilance compliance according to GVP and the other applicable legislation.

· Act or supervise the role of QPPV or Local Pharmacovigilance Contact for clients where required.

· Interface with Competent Authorities, clients and partners for inspections, audits and compliance issues.

· Supervise and train the internal team of Pharmacovigilance Experts and Medical Writers.

· Participate in the definition of technical offers and the development of Pharmacovigilance services.

Requisite Qualifications and Proficiencies:

· Degree in scientific disciplines (Pharmacy, Medicine, Biology, or similar).

· At least 5 years of experience in Pharmacovigilance, preferably in consulting agencies, CROs or companies.

· Excellent knowledge of GVP.

· Direct experience or strong familiarity with the role of QPPV/Local Pharmacovigilance Contact.

· Fluent English (C1 level) essential for handling clients and Competent Authorities.

· Strong interpersonal and management skills and consulting orientation.

Application Procedure:

Interested candidates are invited to send a Curriculum Vitae and a presentation letter, outlining in detail their suitability for the above position, to specifying in the object of the e-mail "Application for Director of Pharmacovigilance".

PMC functions as an employer adhering to principles of equal opportunity.

Diversity is celebrated, and a steadfast commitment to the creation of an inclusive environment for all personnel is rigorously maintained.

Job Type: Commission