Job Description
Job Description
Title: Safety Scientist
Location: 196 Broadway, Cambridge MA 02139
Duration: 5 Months
Hybrid role – 2-3 days per week with the team onsite
Shift Hours: Monday to Friday – EST time zone but may need to join cross functional team meetings based in Europe (Belgium and the UK)
Job Description:
Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key Client 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 Client global assets to ensure Patient Safety globally.
1. Scientific/Medical Knowledge PV Expertise
- 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 prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.
- Explores positions and alternatives to reach mutually beneficial agreements and solutions.
2. Cross-functional Matrix team participation
- 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 GS 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).
- 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.
3. Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
- Leads presentations on recommendations or safety issues to senior staff members at the Client Senior Governance Committees.
- Has the skillset to interact with confidence, credibility, and influence at all levels of the Client organisation. In addition, is expected to represent Client and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
Required and Must Haves:
- 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
Company DescriptionWe believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.
Company Description
We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.