Pharmacovigilance Manager

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.

The importance of patient safety is acknowledged and a requisition is active for a dedicated and experienced Pharmacovigilance Manager to integrate with the team and contribute significantly to the robustness of drug safety operations.

Positional Overview:

Pharmacovigilance Manager shall be responsible for the diligent administration and precise coordination of Pharmacovigilance activities, ensuring the safety of PMC clients' products and rigorous adherence to regulatory mandates. This role encompasses the meticulous supervision of case processing, substantive contribution to safety reporting, active participation in signal detection activities, and the comprehensive provision of support to the overarching Pharmacovigilanc system.

Principal Responsibilities:

• Manage and coordinate Pharmacovigilance projects for national and international clients (case processing, PSUR, RMP, signal detection, PSMF, DSUR, literature screening).
• Ensure compliance with GVP and the other applicable legislation.
• Supervise the Pharmacovigilance team, planning activities and monitoring the quality of work.
• Interface with clients for technical support, design updates and resolution of critical issues.
• Verify and approve Pharmacovigilance deliverables (ICSRs, periodic reports, SOPs).
• Participate in regulatory audits and inspections, contributing to the drafting of CAPAs and process reviews.
• Promote continuous improvement of operational flows and Pharmacovigilance systems.
• Contribute to the training and updating of the team.

Requisite Qualifications and Proficiencies:

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

· At least 3-5 years' experience in Pharmacovigilance, preferably in a consulting and/or CRO.

· Solid knowledge of GVP and post-marketing Pharmacovigilance activities.

· Excellent organisational skills, attention to detail and aptitude for team and project management.

· Fluent English (minimum level B2/C1), written and spoken.

• Proactivity, customer orientation and excellent communication skills.

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 Pharmacovigilance Manager".

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