Director (Clinical Safety & Pharmacovigilance)
A new opportunity has arisen for a Director Clinical Safety & Pharmacovigilance to join a world-wide healthcare organisation whose products and services are used to help care for patients who are critically ill. This is a permanent position based in Nyon, Switzerland.
Please note that to be considered for this role you must have the right to work in this location.
- Accountable to conceive and implement a clearly defined tailored safety strategy that serves to characterize the comparative safety profile of the assigned biosimilar products against the matching originator i.e. reference products.
- Appropriately monitor the emerging safety profile of the biosimilar products; this includes the medical review and approval of ICSR, the conduct of periodic signal detection and evaluation exercises, and the compilation and submission of required aggregate periodic reports.
- To communicate emerging safety signals or other notable safety findings to key stakeholders within the company.
- Assess the risk-benefit balance of the assigned biosimilar products and initiate suitable risk management and risk mitigation / minimization activities.
- Ensure that subject safety and the expected product safety specifications are appropriately considered during the design, conduct, analysis and reporting of clinical investigations.
- Maintain a comprehensive level of knowledge about the biosimilar product(s), the matching originator i.e. reference product and the therapeutic area;
- Coach and mentor colleagues in the CSPV group and collaborating functions in the organisation with respect to the safety of the assigned products and the underlying methodology as required.
- Act as a qualified and informed back-up for other members of the CSPV team, as needed.
- Represent clinical safety and pharmacovigilance on cross-functional teams for the assigned biosimilar product(s) in such a way that all negotiated and agreed upon deliverables and deadlines for these teams are met (may be delegated as appropriate).
- Any other assigned duties.
- Robust, mature project leadership and influencing skills.
- Entrepreneurial thinking and striving to move project forward, within budget and timelines.
- Strong team player and excellent networking skills.
- Proven ability to chair meetings effectively.
- Solution and results orientated.
- Willing to cope with resistance and problems; demonstrated ability to work under pressure and achieving strict timeline targets.
- Clinically versed MD with significant experience in pharmaceutical medicine (drug development and/or drug safety/pharmacovigilance).
- Excellent verbal and written communication skills (in English language).
- Industry experience, preferably including both clinical development and pharmacovigilance experience (including medical safety evaluation and safety-based decision making).
- Excellent knowledge of product development process and experience of cross-functional teamwork.
- Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files.
- First-hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good understanding of either the oncology or rheumatology therapeutic area.
- Professional experience in an international environment.
- Several years of industry experience (minimum 10 years).
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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