408212 SERM Assoc Medical Director

Job Description : Job Purpose :

Provides medical / scientific expertise in the safety evaluation and risk management of key Client assets 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.

Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs.

Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of Client 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. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.

Key Responsibilities :

Scientific / Medical Knowledge PV Expertise :

Responsible for signal detection and evaluation activities for assigned products.

Drives production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician).

Authors the SERM safety contribution to global regulatory submissions in partnership with the product physician.

May respond to auditors / inspectors requests for information / additional information and completes corrective and preventative actions (CAPAs) within agreed timelines.

Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation.

Makes sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed. Identifies, evaluates, and recommends solutions to problems.

Committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for quality.

Cross-functional Matrix team leadership :

Supports and Facilitates 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 ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and / or product labelling.

Leads or participates in cross-functional process initiatives and / or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency.

May author / participate in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.

Builds strong collaborative relationships and demonstrates good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes. Ability to coach and mentor others.

Communications (verbal, written) and Influencing (internal PV Governance and External LTs) :

Presents complex issues to senior staff members at the Client Senior Governance Committees.

Demonstrates initiative and creativity in performing tasks and responsibilities. Proactively contributes ideas to improve existing operations.

Proactively contributes ideas to improve existing operations.

Participates in process improvement initiatives within GCSP and contributes to advancement of methodology and process by generating new ideas and proposals for implementation.

Possesses effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team. Listens and responds appropriately to the views and feedback of others.

Robust medical / scientific writing skills are essential, as the preparation of detailed evaluations and reports on major Client products is a core feature of the role.

Effective negotiation, influencing and persuasion to enable others in the matrix to understand own perspective.

Education Requirements :

Health Sciences / Health Care Professional degree required (e.g., BSc, MS, PhD, RN / BSN / MSN, NP, RPh / B Pharm / Pharm D). Advanced degree preferred

Job Related Experience Requirements :

Substantial 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