SERM Associate Medical Director

GSK; Camden Town; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical company in the UK is seeking a safety evaluation specialist to manage signal detection and risk management activities for its products. The ideal candidate will hold a health sciences degree and possess relevant experience in pharmacovigilance. Strong communication skills and the ability to work in matrix organizations are essential. This role offers opportunities for career development and mentoring junior colleagues.

Qualifications

• Relevant experience in pharmacovigilance or drug development.
• Knowledge of international pharmacovigilance requirements.
• Experience working in large matrix organizations.

Responsibilities

• Responsible for signal detection and evaluation activities.
• Ensure accurate evaluation documents for safety data requests.
• Author regulatory periodic reports globally.

Skills

Pharmacovigilance experience

Medical writing skills

Strong communication

Analytical skills

Education

Health Sciences/Health Care professional degree

Advanced degree preferred

Job description

Provides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post‑marketing setting. Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks. Supports the pharmacovigilance and benefit‑risk management of the assigned portfolio of GSK global assets to ensure patient safety globally. If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors.

Key Responsibilities

• Responsible for signal detection and evaluation activities for assigned products.
• Ensure that accurate and fit‑for‑purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.
• Assist in the production of Risk Management Plans (RMPs)/Risk Tables for designated products, in consultation with senior personnel.
• Author regulatory periodic reports and associated documentation globally according to the agreed process and timelines – reviews and contributes to production of program documents such as protocols and aggregate safety reports.
• Act as a member of a process improvement initiative team within GCSP.
• Complete any post audit/inspection activities within the required timeline.
• Use a range of sources and methods to gather information, identify and propose potential solutions for addressing issues/problems, and make decisions with consultation of SERM physician.
• Show commitment to the task and effective time management to meet multiple deadlines successfully and with attention to detail and quality; able to prioritise own workload with minimal guidance.
• Build effective working relationships and respond to the needs of line functions in the matrix in relation to safety issues.
• Support safety governance/SRTs in the clinical development and post‑marketing settings by assisting in the establishment and operation of cross‑functional teams in any SERM to detect and address product safety issues and ensure that risk‑reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
• Handle mentoring of junior SERM colleagues, can contribute to evaluating the activities of junior colleagues; can explain knowledge and skills, and work in new situations. Early capability for Safety Lead role.
• Communications (verbal, written) and influencing – internal PV governance and external LTs.
• Share ideas with line manager on ways to improve processes for assigned tasks.
• Able and willing to adjust behaviours and priorities based on changing environment.
• Able to deal with ambiguity and remain resilient, focused, and optimistic under pressure.
• Show effectiveness in both oral and written communication; able to effectively express ideas and incorporate feedback into deliverables to create a quality output.
• Demonstrate thorough medical/scientific writing skills – preparation of detailed evaluations and reports is a core feature of the role.
• Support a safety risk position.
• Keep manager/supervisor informed of progress and activities; escalates issues as appropriate.
• Present merits of own point of view.

Qualifications

• Health Sciences/Health Care professional degree required as a medical doctor/physician. Advanced degree preferred.
• Relevant experience in pharmacovigilance or drug development.
• Pharmacovigilance experience relating to safety evaluation and risk management, encompassing both clinical development and post‑marketing activities.
• Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
• Experience working in large matrix organizations.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.