Safety Scientist

Job Description

Job Description

Description

Provides in-depth medical / scientific expertise in the safety evaluation and risk management of key assets or 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 global assets to ensure Patient Safety globally.

Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.

Leads the safety component of global regulatory submissions.

Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.

Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information / factors and understanding of the wider context.

Demonstrates highly developed multi-tasking skills, ability to prioritize tasks and consistently delivers on deadlines, with high performance standards for quality.

Explores positions and alternatives to reach mutually beneficial agreements and solutions.

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.

Represents on cross-functional Clinical Matrix Teams and / or Project Teams.

Leads cross-functional ad hoc teams to address urgent and important product safety issues.

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.

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

Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV).

In addition, is expected to represent and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.

Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting.

Ability to coach and mentor others.

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

Leads presentations on recommendations or safety issues to senior staff members at the Senior Governance Committees. Has the skillset to interact with confidence, credibility, and influence at all levels

Requirements

Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, Drug Safety or a related field.

Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities

Relevant Degree qualification - PhD PharmD - Medic or MD also to be considered

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

Experience in vaccine safety

Strong people management skills - managed a team with direct reports

7+ years of experience

Director level experience would be a bonus

Associate director level experience would be a bonus

Fluent in English - No other language requirements

Strong communication and presentation skills

Scientific / Medical Knowledge PV Expertise

Benefits :

Healthcare Insurance : Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance : Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan : The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus : Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.