SERM Principal Scientist

Key Responsibilities :

1.Scientific / Medical Knowledge PV Expertise :

Responsible for signal detection and evaluation activities for assigned products.

Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.

Assists in the production of Risk Management Plans (RMPs) / Risk Tables for designated products, in consultation with senior personnel.

Authors 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.

Acts as a member of a process improvement initiative team within GCSP.

Completes any post audit / inspection activities within the required timeline

Uses a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues / problems, and makes decisions with consultation of SERM physician.

Shows commitment to the task and effective time management to meet multiple deadlines successfully and with attention to detail and quality. Able to priorities own workload with minimal guidance.

2.Cross-functional Matrix team leadership :

Builds effective working relationships and responds to the needs of line functions in the matrix in relation to safety issues.

Supports 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.

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.

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

Shares ideas with line manager on ways to improve processes for assigned tasks.

Ability and willingness to adjust behaviors and priorities based on changing environment.

Able to deal with ambiguity and resilient, focused, and optimistic under pressure.

Demonstrated effectiveness in both oral and written communication. Able to effectively express ideas and incorporate feedback into deliverables to create a quality output.

Thorough medical / scientific writing skills are important, as the preparation of detailed evaluations and reports is a core feature of the role.

Supports a safety risk positions

Keeps manager / supervisor informed of progress and activities; escalates issues as appropriate.

Able to present merits of own point of view.

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 :

Relevant experience in pharmacovigilance or drug development.

10-13yr of 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.

Scope of Accountability :

Safety signal detection, assessment, and risk management. May chair Safety Review Team.

Provides medical / scientific knowledge in the safety evaluation and risk management of Global pharma company products in clinical development and / or the post-marketing setting.