Full-Time Medical Director (Pharmacovigilance)
Ergomed is hiring a remote Full-Time Medical Director (Pharmacovigilance). The career level for this job opening is Manager and is accepting Zagreb, Croatia based applicants remotely. Read complete job description before applying.
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Ergomed
Job Title
Medical Director (Pharmacovigilance)
Posted
Career Level
Full-Time
Career Level
Manager
Locations Accepted
Zagreb, Croatia
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Job Details
The Medical Director will lead, educate, mentor and develop the team of PV physicians to ensure their competence. The role requires active monitoring of costs and interacting with the pharmacovigilance operational team.
For the Client:
- Assignment of the PV physicians to client projects and ensuring quality, compliance, and efficiency.
- Acting as the point of contact with any Client issues.
- Maintaining good client relations and ensuring a consistently high quality of work for each client.
- Attending regular client meetings to present/discuss safety data.
- Ensuring the integration, analysis and interpretation of safety information, including medical review of individual case safety reports, signal detection and validation.
- Providing expert safety input to the clinical development program.
- Ensuring that Investigator’s Brochures, Clinical Study Protocols and Study Safety Plans include a formal check of all areas related to PV Physician related activities.
- Reviewing or drafting responses to requests on all drug safety matters from Competent Authorities.
- Involvement in the development/review of Risk Management Plans/ Periodic Safety Update reports.
- Actively participating in the Drug Safety Review Committee - signal detection and risk evaluation process.
- Provides high level consultancy to clients on issues relevant to medical aspects of pharmacovigilance.
For the Company:
- Oversees and manages the group of pharmacovigilance physicians and is responsible for the quality, compliance, and timeliness of their work.
- Working cross-functionally with multiple disciplines to provide guidance on productive cross functional medical safety collaborations for clients.
- Support quality and efficiency strategies within the organisation.
- Creates strategy for the team, ensuring adherence by contributors via oversight of metrics reports.
- Oversees key performance indicators of deliverables prepared by key stakeholders, e.g., Clients, compliance team, quality team.
- Supporting and overseeing development of risk-based assessments and mitigation plans and its execution within medical department.
- Ensuring appropriate escalation of potential quality issues to other senior management and its follow up till resolution.
- Support the Business/Commercial team in pharmacovigilance medical aspects of the development of contracts and proposals.
- Support the Company by attending bid defense meetings and conferences as the medical expert, as required.
- PV medical training presentations and delivering PV medical training as required.
- Developing of medical SOPs based on the Company needs and regular updates of the existing SOPs within the applicable targets.
- Maintains PrimeVigilance awareness of developments in the scientific and medical aspects of pharmacovigilance and pharmacoepidemiology.
- Acts as EEA QPPV and/or Deputy for up to 2 clients if required.
The Medical Director should be medically qualified as a physician. Minimum of 15 years of experience including experience in clinical research as well as pharmacovigilance is required.
Experience in reviewing of different aggregate report types is mandatory. Experience as a Qualified person for pharmacovigilance is essential.
Prior experience managing multiple strategy formulations. Comprehensive knowledge of and practice in global Pharmacovigilance regulatory environment
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time Medical Director (Pharmacovigilance) at Ergomed is
1st of November 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
Zagreb, Croatia
] applicants. .
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