Job Description

Senior Director. Global Medical Safety & Pharmacovigilance

Office & Part Remote based – 4 days office based weekly (Fixed)

Ideal Localities: Boston, MA. United States

Employment Type: Full time. Employed.

Experience Background: Pharmacovigilance & Medical Safety – Biotech/Biopharma (Or) Innovative Research & Development

Our client is an innovative Biopharma, with ongoing developments and commercialised therapies aimed at transforming treatments for a range of Cardiovascular conditions.

To continue the future trajectory and evolving needs for the commercialised and development programs, our client is seeking an innovative, motivated and self-leading industry experienced Pharmacovigilance and Safety expert.

You will work closely connected with a small dedicated and passionate PV and associated Medical and Regulatory group, located both at the US HQ operation and across wider Global divisions.

The Senior Global Medical Safety Director will take ownership and a lead direction for the associated Medical Safety and PV projects and tasks. Steering both self-initiated direction and innovative thinking for continued success of commercialised products and associated deliverables for Safety Vigilance Research & Development projects.

Additional responsibilities will also include the ongoing management and direct collaboration with the associated CRO support group, plus adding value, design and input to ongoing and future Pharmacovigilance and Medical Safety deliverables for both the commercialised and development projects.

A broad combined industry and research based Pharmacovigilance and Safety background is ideally sought. Current or prior associated experience working in an innovative and developing Biopharma or Biotech organisation would also be highly advantageous, combined with the associated self-lead responsibilities and experience of working as a key member of a new Pharmacovigilance and Safety group, from early inception and set up stage.

The ideal candidate will have a creative and innovative approach to projects and future Safety direction, combined with a collaborative style of working with associated colleagues. A success driven attitude to ‘making things happen’. You will be self-motivated to take the lead as needed and drive direction and suggestions, combined with the full team support for associated Pharmacovigilance and Safety tasks.

Key Experience and relative aligns required:

• 10+ Years direct industry relative experience in Safety and Pharmacovigilance
• Bachelor’s degree in Life Sciences or Healthcare (And/Or) – PharmD / PhD
• US Citizenship or eligibility to work in USA
• Agreeable to work office based - 4 days weekly (1 day remote based)
• Experience in Research & Development – Ideally from Phase 1 or 2 onward
• Solid understanding of drug pharmacology, clinical development and regulatory processes
• Proven abilities in taking self-lead and ownership of assigned projects as required
• Experience and understanding of associated global Pharmacovigilance regulations
• Experience in conducting safety data reviews for investigational and ideally also, post-marketed products
• Proven credentials to both contribute and review standard operating procedures (SOPs) and associated Safety/Vigilance documents
• Prior involvements with Global PV operations – Highly advantageous, including direct involvements and collaboration in global PV decision processes and future strategies, plus self-management of associated tasks
• Full adherence and commitment to both compliance and ethical standards
• Experience in management of safety content and collaboration with Regulatory and Medical departments
• Experience in creation and completion of associated aggregate reports, including: PBRER, DSUR, PADER and ad-hoc queries or reports – For submission to regulatory agencies
• Experience in contributing to the safety Risk Management Plans (RMPs) and lead oversight and involvements in associated Safety Review Team meetings and Signal Detection Activities

A competitive salary and full associated package benefits are on offer

To Apply

In the first instance please send your CV and any relevant support details for consideration.

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