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Looking to escape your long commute to work? Unlock your new remote working position with this exciting role in pharmacovigilance!

Proclinical is seeking a SERM Medical Director to supply expertise in safety evaluation and risk management for clinical trials and post-marketing settings. This role focuses on ensuring patient safety through the review, interpretation, and management of adverse event data. The ideal candidate will have experience in medical review of adverse events, pharmacovigilance databases (e.g., Argus), and cross-functional leadership.

Responsibilities:

• Conduct medical reviews of adverse events from clinical trials, ensuring scientifically sound assessments.
• Develop and execute safety strategies, including contributions to global regulatory submissions.
• Provide expert evaluation of clinical data, literature, and safety signals to support decision-making.
• Collaborate with cross-functional teams to address product safety issues and implement risk-reduction strategies.
• Represent safety governance in internal and external meetings, including regulatory discussions.
• Author and contribute to updates of standard operating procedures (SOPs) to ensure compliance with regulations.
• Lead or participate in process improvement initiatives to enhance data quality, efficiency, and adherence to standards.
• Mentor and coach team members, fostering a collaborative and high-performing environment.

Key Skills and Requirements:

• Medical degree (e.g., MD, veterinarian, dentist) or equivalent with relevant pharmacovigilance experience.
• Expertise in adverse event case review and medical assessment within clinical trials.
• Proficiency with drug safety databases such as Argus or similar systems.
• Strong analytical skills for data synthesis, interpretation, and problem-solving.
• Demonstrated ability to lead cross-functional teams and manage safety governance processes.
• Excellent communication and influencing skills, with experience presenting to senior stakeholders.
• Familiarity with regulatory requirements and global safety standards.
• Ability to multitask, prioritize, and deliver high-quality results under tight deadlines.