POSITION SUMMARY: Legal Specialist (PV)
Provide legal support to the companies global safety organisations across the pharmaceutical and consumer sectors in relation to the generation, negotiation and maintenance of safety-related agreements. Providing general ad-hoc pharmacovigilance (PV) legal advice and support.
1. Draft safety-related agreements for commercial agreements (i.e. in-licensing and out-licensing agreements with PV obligations, and clinical trial collaboration agreements that may result in licensing agreements with third parties), including safety provisions for inclusion in master agreements and PV transition agreements. Draft internal service level agreements (SLAs).
2 Assist with safety-related agreement negotiations, working closely with various internal and external business partners.
3. Assist with creating templates or standard wording on safety-related matters, and maintaining such templates.
4. Provide legal support before, during and after internal audits and Health Authority inspections with respect to safety-related agreements.
5. Assist with generation of the PSMF list of commercial contracts.
6. Provide general ad hoc legal advice and support (including training).
DECISION-MAKING AND PROBLEM-SOLVING:
Carry out legal research. Advise on, draft and negotiate safety-related agreements with respect to global and local regulatory implications. Advise on and draft other types of safety-related agreements (eg. PV provisions for divestiture and acquisition agreements, safety transition agreements, termination letters).
Ability to work in a matrix organization forming close liaisons with internal business partners, including the global safety organisations, local safety officers, BRQC, and Regulatory Affairs, to support decision-making.
Reporting directly to the Legal Director – Regulatory Law EMEA & Global Safety or one of her direct reports supporting the global safety organisations of the pharmaceutical and consumer sectors of the company.
Liaison with safety organisations within the consumer and pharmaceutical sectors on safety agreements (daily).
Liaison with internal/external business partners in negotiating safety agreements (3-4 days a week)
Participate in periodic calls with safety groups (eg. PAC, Cross-sector Safety Leads, Country Safety Team Leads and Local Safety Officers) (weekly)
Liaison with internal business partners (e.g. safety organisations (consumer and pharma), BRQC) providing advice, training and support (weekly)
Liaison with BRQC supporting internal audit and inspection requests (weekly)
EDUCATION & EXPERIENCE REQUIREMENTS:
At least a University degree in Law or equivalent. Minimum 3 years general commercial law experience required (in a leading law firm or in the legal or contracts department of a major multinational company, with previous in-house experience preferred). Contract drafting and negotiation experience a particular requirement. Proactive and self- reliant with a sense of responsibility, ownership and urgency coupled with an understanding of when to reach out to manager for supervision. Works well under pressure, good time management, intellectual curiosity, results orientated, attention to detail, strategic thinking, collaboration & teaming, inner confidence, self-awareness and adaptability required. Demonstrates willingness to listen and learn and proven ability to make and respectfully explain proper decisions (even when this leads to tough business discussions).
This job was originally posted as www.totaljobs.com/job/77200659