Registered Nurse

Immploy Recruitment; Cape Town; On-site; ZAR 1,000,000 - 1,350,000; Full time

Job summary

Immploy Recruitment seeks an Associate Medical Safety Director to join a sponsor-dedicated Lifecycle Safety team. The role covers pharmacovigilance, signal detection, risk management, and safety reporting across product portfolios with global regulatory alignment.

The candidate should hold a medical degree with about three years of clinical practice and two years in the pharmaceutical industry, plus knowledge of applicable regulations and the ability to synthesize complex data for safety

Qualifications

• Medical degree from an accredited medical school.
• Experience with safety signals, risk management and pharmacovigilance processes.
• Strong knowledge of regulatory requirements and health authority expectations.
• Ability to synthesize complex clinical data for safety evaluations.
• Excellent communication with internal and external stakeholders.

Responsibilities

• Provide medical safety oversight across products including signal detection strategy and safety reviews.
• Prepare and contribute to safety reports and regulatory submissions.
• Review adverse event data, CTD modules and safety narratives.
• Collaborate with cross-functional teams and vendors on PV activities.

Job description

Associate Medical Safety Director- Sponsor Dedicated

Locations: Belgrade, Serbia; Budapest, Hungary; Sofia, Bulgaria; Bellville, South Africa; Istanbul, Turkey; Lisbon, Portugal; Bloemfontein, South Africa; Zagreb, Croatia; Athens, Greece; Centurion, South Africa; Prague, Czech Republic; Evosmos, Greece; New Cairo, Egypt

Contract type: Full time

Job description: Our ever‑growing Lifecycle Safety Medical team is expanding. The role participates in all aspects of the Medical Safety activities as per scope of work. This includes providing and maintaining PV and risk management expertise to internal and external stakeholders, maintaining knowledge relevant to allocated product portfolios, conducting medical evaluation of post‑marketing adverse drug reactions, review and contribution to signal management and benefit‑risk evaluation of drugs in clinical trial and post‑marketing set up, preparation and/or contribution to responses to questions from health authorities, reviewing and contributing to periodic aggregate reports, contributing to safety review of study protocols, investigators brochure and other reference safety information, and serving as an internal consultant for any medical support for pharmacovigilance operations.

• Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile.
• Leads signal detection and analysis, including signal detection strategy, frequency, and timing, reviews the Signal Detection Reports and other sources of data as applicable, raises potential signals for team discussion, contributes to safety analysis reports presentations of signal evaluation data as appropriate.
• Providing medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports.
• Providing medical review and contribution to Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies.
• Review and contribute to benefit‑risk evaluation of drugs in clinical trial and post marketing set up.
• Providing safety oversight and contribution for label development, review, and updates.
• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document.
• Performing medical review and clarification of trial‑related Adverse Events (AEs) and post‑marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary and serve as an internal consultant to pharmacovigilance case processing teams.
• Representing safety and clinical data review findings during internal and external stakeholder meetings.
• Providing medical safety support, contribution, and attendance at Safety Governance and other Meetings as needed.

• A medical degree from an accredited and internationally recognised medical school.
• Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience.
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including safety and good clinical practice and clinical trials and pharmaceutical research process.
• Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature.
• Experience in Signal detection, Aggregate reports and Risk management.
• Capability to synthesize and critically analyse data from multiple sources and communicate complex clinical issues and analyses orally and in writing.
• Ability to establish and meet priorities, deadlines, and objectives.
• Demonstrated skills in contributing to multiple assignments required, capacity to work under pressure as well as initiative and flexibility and ability to adapt to changing business needs.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed.

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